Surg Endosc DOI 10.1007/s00464-014-3448-3
and Other Interventional Techniques
Day-case versus inpatient laparoscopic fundoplication: outcomes, quality of life and cost-analysis C. Gronnier • A. Desbeaux • G. Piessen J. Boutillier • N. Ruolt • J. P. Triboulet C. Mariette
• •
Received: 7 October 2013 / Accepted: 13 January 2014 Ó Springer Science+Business Media New York 2014
Abstract Background Day-case laparoscopic Nissen-Rossetti fundoplication (LF) has been demonstrated to be safe in small, prospective cohorts. The purpose of the study was to compare postoperative course, functional results, quality of life, and healthcare costs in patients undergoing LF in a day-case surgical unit with same-day discharge and patients undergoing LF as an inpatient. Methods All consecutive patients in our department who underwent a primary LF for symptomatic uncomplicated gastroesophageal reflux disease from 2004 to 2011 were entered into a prospective database (n = 292). From 101 same-day discharge patients (day-case group), control
C. Gronnier A. Desbeaux G. Piessen J. Boutillier N. Ruolt J. P. Triboulet C. Mariette (&) Department of Digestive and Oncological Surgery, University Hospital Claude Huriez, Centre Hospitalier Re´gional Universitaire, Place de Verdun, 59037 Lille cedex, France e-mail: [email protected] C. Gronnier e-mail: [email protected] C. Gronnier A. Desbeaux G. Piessen J. Boutillier N. Ruolt J. P. Triboulet C. Mariette Ambulatory Department, University Hospital Claude Huriez, Centre Hospitalier Re´gional Universitaire, Place de Verdun, 59037 Lille cedex, France C. Gronnier G. Piessen J. Boutillier J. P. Triboulet C. Mariette University Lille Nord de France, Place de Verdun, 59045 Lille cedex, France C. Gronnier G. Piessen C. Mariette Inserm UMR 837, Team 5 ‘‘Mucins, Epithelial Differentiation and Carcinogenesis’’, JPARC, Rue Polonovski, 59045 Lille cedex, France
inpatient procedures were randomly matched by age, gender, body mass index, American Society of Anesthesiologists classification, and presence of a hiatal hernia (inpatient group, n = 101). Results No postoperative deaths occurred and postoperative morbidity occurred in 9.4 % of patients. When comparing day-case and inpatient groups, postoperative morbidity rates were 9.9 vs. 8.9 % (p = 0.81) with median hospital stays and readmission rates of 1 vs. 4 days (p \ 0.001) and 7.9 vs. 0 % (p \ 0.001), respectively. Gastrointestinal Quality of Life Index was significantly enhanced due to surgery (p \ 0.001) and comparable in the two groups. Estimated direct healthcare costs per patient were 2,248 euros in the day-case group vs. 6,569 euros in the inpatient group (p \ 0.001), equivalent to a cost saving of 3,921 euros. Conclusions Day-case and inpatient approaches after LF give similar results in terms of postoperative mortality and morbidity, functional outcomes and quality of life, with a substantial cost saving in favor of a day-case procedure. Keywords Laparoscopic fundoplication Reflux Day-case surgery Functional results Quality of life Medico-economic analysis
Day-case surgery has developed over the past three decades for numerous reasons, which include improvements in surgical instruments, the development of minimally invasive techniques, improvement in anesthesia with better control of postoperative nausea and postoperative pain, and specially trained daycare teams. The necessity to reduce healthcare costs and waiting lists also has been a driving force behind this change in practice. Following the first report in 1991 [1], laparoscopic fundoplication (LF) has
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become the surgical approach of choice for gastroesophageal reflux disease (GERD), because it reduces patient length of stay, is associated with better pain control, and facilitates a more rapid postoperative recovery compared with the open approach [2, 3]. Given these benefits of LF, we and others, in small prospective cohorts, have reported the feasibility and the safety of day-case LF in motivated and fit patients [4–7]. Before considering day-case surgery as the standard procedure, postoperative course, functional results, and quality of life should be evaluated and compared with the conventional inpatient procedure. To our knowledge, to date such an evaluation has not been reported. The objective of our study was to test the hypothesis that day-case and inpatient LF for GERD give comparable results but with substantial cost differences. We compare, through a matched case–control study, 30-day postoperative morbidity and mortality, functional results, health-related quality of life (HRQOL), and direct healthcare costs of day-case and inpatient LF.
Patients and methods Data were collected prospectively for all consecutive patients benefiting from a primary Nissen-Rossetti fundoplication for symptomatic uncomplicated GERD between January 2004 and October 2011. The French North-West Ethical Committee approved the study on July 10, 2008. Eligibility criteria were defined according to published literature and day-case requirements to minimize intraoperative complications and/or conversions. Patients considered for day-case LF included patients with GERD without a large hiatal hernia or prior upper abdominal surgery, an American Society of Anesthesiologists (ASA) grade I or II, with good understanding of the care protocol, living within a 1 h drive from hospital, and those who would have adult company at home until the morning after discharge. Patients were not considered for a day-case procedure if living more than a 1 h drive from hospital, they refused an operation as a day-case, or they lived alone at home. Other exclusion criteria from day-case surgery included comorbidities precluding day-case surgery; such conditions included diabetes, coronary artery disease, epilepsy, chronic pulmonary disease, and morbid obesity (body mass index (BMI) [ 40 kg/m2). Day-case patients were matched according to age (±5 years), gender, BMI (±5 kg/m2), ASA score, and presence of a hiatal hernia to control patients with the same characteristics who underwent LF as an inpatient. Patients who had had previous abdominal surgery, an ASA score of III or IV, had a large hiatal hernia, and/or complicated GERD were excluded from the study.
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Preoperative workup All patients benefited from preoperative surgical and anesthetic consultations. Upper digestive endoscopy was routinely performed to identify complications of GERD and/or large hiatal hernias ([5 cm). Esophageal motility was routinely assessed by preoperative esophageal manometry. A 24 h pH-metry was performed in cases of non typical clinical symptoms of GERD. When surgical treatment was discussed, patients were informed about the surgical procedure, expected postoperative course, and possible postoperative problems and complications. The information also was provided on a detailed information sheet, and all patients gave written informed consent. Preoperative management In the day-case group, the perioperative management followed a detailed therapeutic protocol, as described previously [7]. A phone call was performed the day before surgery and the day after surgery as a reminder and to answer potential questions. On the day of the operation, patients arrived at 7:30 a.m., and the intervention started at 9:00 a.m. In the inpatient group, patients were admitted the day before surgery and the operation was performed the following morning. Surgical approach A laparoscopic Nissen-Rossetti, without division of the short gastric vessels and with sutured crural closure, was performed in all patients. Major intraoperative events, such as intraoperative blood loss requiring transfusion, esophageal injury, or conversion to laparotomy were contraindications to same day discharge. Long-acting local anesthetic was systematically placed under the diaphragm (2 9 15 ml of bupivacaine 2.5 mg/ml) and 10 ml of the same product was infiltrated into the wounds at the end of the procedure in all patients. A nasogastric tube of 21-French was routinely used to help calibrate the valve and was removed before extubation. Postoperative management Day-case group Postoperative pain was managed by i.v. paracetamol (1 g) administered 30 min before the end of surgery. In addition, i.v. ketoprofen (100 mg) and tramadol (100 mg) could be administered in the recovery room if the patient’s pain score was greater than 4, estimated by a 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain). In order to prevent postoperative nausea and
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vomiting (PONV), patients systematically received intravenous ondansetron 4 mg. All patients were given oral fluids and soft solids after transfer from the recovery room to the postoperative observation unit with early mobilization. Patients were scheduled to leave before 6:00 p.m. If deemed unsuitable for discharge, they were admitted for an overnight stay. Before departure, systematic chest x-ray and hemoglobin measurement were performed, and patients were examined by both the responsible surgeon and the anesthetist in charge of the operation. They were given a standard package of analgesics on discharge consisting of tramadol (100 mg three times daily), paracetamol (1 g three times daily), a nonsteroidal anti-inflammatory (100 mg twice daily), and metoclopramide (10 suppositories) for 5 days. Information regarding what postoperative symptoms may be expected was repeated, and an information leaflet also was given to both patients and relatives. This included relevant contact telephone numbers. Patients were routinely contacted by the surgeon the next day and were seen in consultation after 5 days, 3 months, 6 months, and annually thereafter.
(range 0–144). It measures specific and general HRQoL by including measures of overall HRQoL. Five dimensions of HRQoL were evaluated: (1) symptoms (0–76 points), (2) physical condition (0–28 points), (3) feelings (0–20 points), (4) social integration (0–16 points), and (5) medical treatment (0–4 points). The higher the score on the GIQLI, the better the HRQoL is. An estimate of direct perioperative costs was performed, based on costs fixed by our institution and the CNAMTS (French national health insurance) [10]. Were considered costs related to surgical consultation (26 euros) with one preoperative and one postoperative consultation, anesthetic consultation (26 euros), conventional hospitalization (1,554 euros ? 18 euros—unit cost for each day of hospitalization), unit cost for a single day-case bed (832 euros), standard hospital operation costs (397.5 euros), standard cost for a converted surgical procedure (322.6 euros), reoperation by laparoscopy (397.5 euros) or by laparotomy (322.6 euros), any additional consultation (26 euros), and cost of hospital readmission (1,554 euros ? 18 euros of daily unit cost for each day of hospitalization). Statistical analysis
Inpatient group Patients systematically remained in the hospital for at least one night following surgery. Systematic postoperative chest x-ray and hemoglobin measurement were performed, and patients were given oral fluids and soft diet on the same day of surgery, as permitted by the presence or absence of PONV. The responsible surgeon discharged the patient usually 1 or 2 days after surgery after clinical examination, optimal management of both pain and PONV, with a soft diet recommended for 3 weeks. Patients were routinely seen in consultation after 3 months, 6 months, and annually thereafter.
Median follow-up was 62 months [5–109]. Two patients were lost to follow-up, one in each group. Data were collected in a prospective database and analyzed in intent to treat, using SPSSÒ version 15.0 software (SPSS, Chicago, IL). Data were presented as prevalence, means (standard deviation), or median (range). Continuous data were compared by means of the Mann–Whitney U test and ordinal data by the Chi square test or Fisher exact test as appropriate. P \ 0.05 was considered statistically significant.
Results Parameters studied Demographic and preoperative data All peri- and postoperative data were recorded in intent to treat by independent observers (JB and GP). In addition to per- and postoperative courses, dedicated endpoints for daycase patients were recorded, including hospital admissions, nonscheduled consultations, or hospital readmission. Functional results were evaluated at 3 (±1) months and 24 (±6) months, taking into account recurrence of GERD symptoms, need for antireflux medication, dysphagia, gas bloat syndrome, and the performance of any further invasive procedures. The Visick validated scoring system was used to evaluate patients’ satisfaction [8]. Quality of life was evaluated before and after surgery using the Gastrointestinal Quality of Life Index (GIQLI) [9]. The GIQLI contains up to 36 items scored on a 5-point Likert scale
Between January 2004 and October 2011, a LF was performed in 292 consecutive patients. All day-case patients (n = 101) were compared to comparable patients undergoing surgery as an inpatient after matching by age, gender, BMI, ASA score, and presence of a hiatal hernia (n = 101; Table 1). In the study population (n = 202), 116 patients were men (57.4 %), with an ASA score of I (70.8 %) or II (29.2 %). The median age was of 39.4 years [16–72] and the median BMI was 26.0 kg/m2 [17–48]. As expected, the day-case and the inpatient control groups had comparable demographic data (Table 1). The median duration of the intervention was 79 min [32–176] in the day-case group
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Surg Endosc Table 1 Preoperative, peroperative, and postoperative data
Median age [range] (year)
Day-case group N = 101 (50 %)
Control group N = 101 (50 %)
p value
37.4 [15.6–64.1]
41.1 [15.7–72.0]
0.346
ASA score ASA 1 (%) ASA 2 (%)
Table 2 Patients’ satisfaction according to Visick classification
0.877 71 (70. 3 %) 30 (29.7 %)
72 (71.3 %) 29 (28.7 %)
Gender
0.393
Male (%)
61 (60.4 %)
55 (54.4 %)
Female (%)
40 (39.6 %)
46 (45.6 %)
Hiatal hernia
Day-case group N = 101 (50 %)
Control group (%) N = 101 (50 %)
Total N = 202 (100 %)
p value
Visick 1
68 (67.3 %)
67 (66.3 %)
135 (66.8 %)
0.155
Visick 2
21 (20.8 %)
22 (21.8 %)
43 (21.3 %)
At 3 months
Visick 3
3 (3 %)
3 (3 %)
Visick 4
9 (8.9 %)
9 (8.9 %)
18 (8.9 %)
6 (3 %)
Visick 1
58 (57.4 %)
58 (57.4 %)
116 (57.4 %)
Visick 2
20 (19.8 %)
20 (19.8 %)
40 (19.8 %)
At 24 months
0.826
Yes
46 (45.5 %)
45 (44.6 %)
Visick 3
13 (12.9 %)
13 (12.9 %)
26 (12.9 %)
No
55 (54.5 %)
56 (55.4 %)
Visick 4
10 (9.9 %)
10 (9.9 %)
20 (9.9 %)
Median BMI [range] (kg/m2)
25.3 [16.4–38.0]
26.5 [18.8–47.8]
0.437
Median operative time [range] (min)
73 [35–176]
85 [32–166]
0.069
Postoperative morbidity (%)
10 (9.9 %)
9 (8.9 %)
0.81
ASA American Society of Anesthesiologists, BMI body mass index
(73 min [35–176] vs. 85 min [32–166] in the inpatient group, respectively; p = 0.069). Neither patients suffered peroperative complications nor conversion to laparotomy. Thirty-day postoperative course There were no postoperative deaths. The overall 30-day postoperative morbidity rate was 9.4 % (n = 19), 9.9 % (n = 10) in the day-case group, and 8.9 % (n = 9) in the inpatient group (p = 0.81; Table 1). Surgical complications in the day-case group were intrathoracic migration of the fundoplication following uncontrolled and prolonged vomiting (n = 1), severe dysphagia (n = 6), medical treatment of a superficial abscess (n = 3) and, in the inpatient group, severe dysphagia (n = 5) and prolonged nausea (n = 1). No medical complications were noted in the day-case group, whereas acute urinary retention (n = 1), thrombophlebitis (n = 1), and a cutaneous iodine reaction (n = 1) were reported in the inpatient group. Regarding outpatient endpoints in the day-case group, 79 patients (78.2 %) were discharged after operation as planned before 6:00 p.m. Twenty-two patients failed to meet discharge criteria and were admitted directly from the day ward (21.8 %) [dysphagia (n = 4), vasovagal syncope (n = 2), inadequate pain control (n = 4), PONV (n = 9), and anxiety (n = 3)]. Among these patients, 15 (68.2 %) returned home within 24 h after their operation. The median length of stay was 1 day [1–7] in the daycase group versus 4 days [2–10] in the inpatient group
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0.771
(p \ 0.001), with a median length of stay after the surgical procedure of 0 days [0–7] vs. 2 days [1–8], respectively (p \ 0.001). The median delay to recommencing diet was 0 days [0–1] and 1 day [0–3] in the day-case and inpatient groups respectively (p \ 0.001). Unscheduled consultations within 30 postoperative days were reported in seven patients in the day-case group (6.9 %) and three in the inpatient group (3 %, p = 0.194). This was due to dysphagia in five patients in the day-case group and one in the inpatient group, and epigastric pain in two patients in each group. Unscheduled readmissions within 30 days of surgery were reported in eight patients (7.9 %) exclusively in the day-case group, including severe dysphagia requiring reoperation (n = 3), pyrexia related to bronchitis (n = 1), wound abscess (n = 1), and vomiting (n = 3). Functional results At 3 months, 88.1 % of patients (n = 178) had excellent to very good results (Visick 1 and 2), 3 % (n = 6) had acceptable results (Visick 3), and 8.9 % (n = 18) had unsatisfying results (Visick 4). At 24 months, minor changes to patient satisfaction ratings were noted with 77.2 % (n = 156) Visick 1 and 2, 12.9 % (n = 26) Visick 3, and 9.9 % (n = 20) Visick 4 (Table 2). No significant differences in satisfaction ratings were observed between day-case and inpatient groups at either time point. With regards to control of symptoms of GERD, 8.9 % of patients (n = 18) reported some GERD symptoms at 3 months: 7.6 % (n = 8) in the day-case group vs. 9.9 % (n = 10) in the inpatient group (p = 0.395). At 24 months, 20.3 % of patients (n = 41) reported some symptoms of GERD: 20.8 % (n = 21) in the day-case group vs. 19.8 % (n = 20) in the inpatient group (p = 0.501). Seven patients (3.5 %) were reoperated on for recurrence of symptoms of
Surg Endosc Table 3 Quality of life evaluation according to the GIQLI score Day-case group (mean ± SD)
Control group (mean ± SD)
Total (mean ± SD)
p value
Total 89.2 (±24.8)
81.8 (± 26.2)
Postoperative score after 3 months
Preoperative score
112.5 (±20.1)
101.7 (± 22.6)
Postoperative score after 24 months
94.6 (±24.6)
98.2 (± 24.5)
86.4 (±25.4) 108.2 (±22) 97.2 (±24.8)
0.778 0.348 0.499
Symptoms Preoperative score
48.1 (±11.7)
44.5 (± 11.3)
46.4 (±11.7)
0.667
Postoperative score after 3 months
56.9 (±11.3)
52.3 (± 11.9)
53.8 (±14)
0.501
Postoperative score after 24 months
49.0 (±11.6)
49.1 (± 14.6)
49.0 (±12)
0.264
Physical condition Preoperative score
15.0 (±7.2)
13.6 (± 8.2)
14.3 (±7.7)
0.309
Postoperative score after 3 months Postoperative score after 24 months
21.3 (±5.2) 16.0 (±6.9)
18.8 (± 5.9) 17.5 (± 8)
19.9 (±6.2) 16.5 (±7.1)
0.988 0.521
11.9 (±4.6)
10.7 (±4.7)
11.4 (±5.2)
0.055
Emotion Preoperative score Postoperative score after 3 months
16.8 (±4.2)
14.6 (±5)
15.6 (±5)
0.858
Postoperative score after 24 months
13.7 (±4.9)
13.6 (±3.9)
13.6 (±3.5)
0.129
Social integration Preoperative score
11.3 (±4)
10.7 (±4.1)
11.0 (±4.1)
0.19
Postoperative score after 3 months
14.0 (±3)
12.6 (±3.8)
13.2 (±3.8)
0.373
Postoperative score after 24 months
12.5 (±3.6)
12.9 (±2.6)
12.6 (±2.5)
0.209
Medical treatment Preoperative score
2.9 (±1.4)
2.4 (±1.5)
2.7 (±1.5)
0.226
Postoperative score after 3 months
3.6 (±1)
3.4 (±1.3)
3.5 (±1.2)
0.656
Postoperative score after 24 months
3.4 (±1)
3.8 (±0.7)
3.6 (±0.5)
0.217
SD standard deviation, GIQLI gastrointestinal quality of life index
GERD: three in the day-case group (3 %) and four in the inpatient group (3.9 %; p = 0.544). Severe dysphagia was reported in 3.9 % of patients at 3 months (n = 8): 3.9 % in the day-case group (n = 4) and 3.9 % in the inpatient group (n = 4; p = 1.000). At 24 months, the overall dysphagia rate was 17.8 % (n = 38), 17.8 % in the day-case group (n = 18), and 17.8 % in the inpatient group (n = 18; p = 1.000). During the study period, reoperation for severe dysphagia was required in 2 % of cases (n = 4): 1 % (n = 1) vs. 3 % (n = 3) in the day-case and the inpatient groups respectively (p = 0.73). Symptoms related to gas bloat syndrome were reported in 4.5 % of patients (n = 9) at 3 months: 5.9 % (n = 6) and 3 % (n = 3) in the day-case and inpatient groups respectively (p = 0.239). At 24 months, the overall rate of gas bloat symptoms was 17.3 % (n = 35): 16.8 % (n = 17) and 17.8 % (n = 18) in the day-case and inpatient groups, respectively (p = 0.775). During the study period, the reoperation rate was 11.4 % (n = 23), with 12 patients (11.9 %) reoperated on in the day-case group and 11 (10.9 %) in the inpatient group (p = 0.618). Fifty percent of reoperations were performed
within the first 6 months following the primary procedure. Indications for reoperation included severe dysphagia (n = 10, 4.9 %), recurrence of GERD symptoms (n = 12, 5.9 %), and fundoplication migration (n = 1, 0.5 %). All reoperations except one were performed laparoscopically. Health-related quality of life Compared with the preoperative setting, the GIQLI was significantly improved for the global score at 3 months (86 ± 25 vs. 108 ± 22, p \ 0.001) and at 24 months (86 ± 25 vs. 97 ± 24, p \ 0.001) after surgery and also in each of the dimensions evaluated; symptoms, physical condition, feelings, social integration, and medical treatment (p \ 0.001; Table 3). There were no significant differences between the day-case and the inpatient groups regarding global scoring or any of the individual dimensions evaluated. Direct healthcare costs evaluation The 101 patients in the day-case group represented a total cost of 227,039 euros, giving a mean cost of 2,248 euros
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Surg Endosc Table 4 Direct healthcare costs estimation
Unit cost (euros) Number of patients
Day-case group
Control group
n
n
Total costs (euros)
101
Total costs (euros)
101
Preoperative surgical consultation
26
101
2,626
101
2,626
Preoperative anesthesia consultation
26
101
2,626
101
2,626
Days of conventional hospitalization
1,554
63
97,902
417
648,018
Daily fixed cost for each day of hospitalization
18
142
2,556
417
7,506
Days of hospitalization in ambulatory sector
832
79
65,728
0
0
Laparoscopic fundoplication Conversion
397.5 322.63
101 0
40,147.5 0
101 0
40,147.5 0
Postoperative surgical consultation
26
112
2,912
104
2,704
Hospital readmission
8
0
Days of conventional hospitalization
1,554
32
49,728
0
0
Daily fixed cost for each day of hospitalization
18
32
576
0
0
Laparoscopic redo surgery
397.5
6
2,385
0
0
Redo surgery by laparotomy
322.63
1
322.6
0
0
Total cost
227,039
663,480
Mean cost by patient
2,248
6569a
a
p \ 0.001
per patient (Table 4). In the inpatient group, the total cost was 663,480 euros for 101 patients, giving a mean cost of 6,569 euros per patient (p \ 0.001). In other words, daycase surgery was responsible for a cost saving of 3,921 euros. Considering that some centers worldwide may propose a hospitalization the morning of surgery, we also evaluated adjusted costs that were 5,015 euros in the inpatient group without the cost of the day before surgery significantly higher than in the day-case group (p \ 0.001), for a remaining saving cost of 2,367 euros.
Discussion Since the beginning of this century, day-case surgery has been performed for both its patient and economic benefits [11]. Day-case surgery accounts for approximately 94 % of eligible surgical procedures in the United States, 78 % in Denmark, 67 % in Holland, 60 % in the United Kingdom, and for only 30 % in France [12]. Improved surgical and anesthetic techniques, as well as cost considerations, means this low rate of day-case surgery is expected to increase significantly with an expansion in the array of procedures, which are deemed eligible. A few recent publications, of retrospectives studies [13, 14] and small prospective cohorts [4–7], have reported the feasibility and safety of day-case LF in motivated and fit patients. These studies were pooled in a recent systematic review [15], but none of them have comparatively evaluated day-case and inpatient
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procedures in terms of postoperative course, functional results, HRQoL, and cost savings. Such an analysis was the goal of the present work. Our study confirms the feasibility of LF in the day-case setting with no postoperative mortality, a low rate of postoperative morbidity (9.4 %), a failure of same day discharge in 21.8 % and nonscheduled consultation and readmission rates of 6.9 and 7.9 %, respectively. Significant morbidity was related to dysphagia in six cases, treated by reoperation, with one serious complication at the beginning of our experience in a patient who suffered intrathoracic migration of the fundoplication following uncontrolled PONV on the day of surgery requiring reoperation with an eventful postoperative course. This patient failed same-day discharge being discharged after one night in the hospital. Such early intrathoracic fundoplication migration also has been described in inpatient series [16]. This complication does not preclude the feasibility of a LF day-case program, but highlights the fact that patients can only be discharged from hospital after strict control of PONV, facilitated by an avoidance of opioids and the use of prophylactic antiemetic protocols adjusted to the Apfel’s 4-item risk score [7–12, 16, 17]. The originality of this work is in showing that functional results and HRQoL after LF are similar for patients treated in a day-case and conventional inpatient setting. In other words, a day-case approach does not impact negatively on the quality of surgical results. It is of importance to underline that day-case surgery is not detrimental to the
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emotional dimension of HRQoL, as it could be hypothesized that significantly decreasing the duration of hospitalization could lead to enhanced patient anxiety. Even if HRQoL is significantly improved by surgery and the results are consistently comparable between the two groups over time, a slight deterioration of the functional results with time is evident. A constant proportion of patients experienced poor functional results regardless of the time point of follow-up (Visick 4 score of 8.9 % at 3 months and 9.9 % at 24 months), mainly related to recurrence of the symptoms of GERD or dysphagia, and probably due to inappropriate patient selection for surgery. A further group of patients will observe slight deterioration of their results with time, reflected by the Visick 3 score growing from 3 % at 3 months to 12.9 % at 24 months, independently of the treatment group. Whilst postoperative mortality is very uncommon in published series (0 % in the present series), postoperative complications, such as dysphagia or gas bloat syndrome, have been frequently reported [18, 19] with respective rates of 17.8 and 17.3 % in our study. There are many advantages of day-case surgery compared with traditional inpatient surgery. These include convenience (the convenience of recovering at home generally makes recovery time quicker and easier than an inhospital stay), decreased prescription of medications, reduced stress, and increased rates of scheduled surgery due to more efficient use of hospital and surgeon’s time. However, the main advantage of the day-case setting is probably financial, and the present study, even allowing for the fact that the cost-analysis has been grossly conducted, exhibits a mean saving cost of 3,921 euros per patient treated. This amount represents approximately 50 % of the direct costs linked to an inpatient LF procedure with 2 days of hospitalization. One can argue than some centers worldwide provide admission the day of surgery and not the day before, leaving also in this situation a cost saving of 2,367 euros. The obvious advantages of day surgery have been already established in countries with a predominantly privately funded healthcare system but remain to be optimized in public hospitals. In digestive surgery, the application of day-case surgery has largely been restricted to hernia repair and cholecystectomy, and hence there is huge potential for its expansion especially for laparoscopic procedures. In selected patients, LF, due to its simplicity and low morbidity, appears to be a good candidate in the drive to expand the number of digestive surgical procedures performed on a day-case basis. A preoperative standardized education program for ambulatory surgery might be useful to better prepare patients for day-case management. This study has some limitations due to its retrospective nature and the fact that some missing data impaired the robustness of HRQoL evaluation. Moreover, having considered only direct and mean costs may have impaired our
cost-analysis, but there are no reasons for thinking that drug medication costs would have modified significantly the results or that having included indirect costs may have linked to opposite results. The matching technique based on numerous and pertinent variables, as well as the inclusion of consecutive and unselected patients and evaluation by independent observers blinded from the treatment group, may have limited the impact of bias on results. A randomized trial with medical and medico-economic endpoints is needed to definitively assert that day-case LF should be the ‘‘gold standard’’ for the surgical treatment of eligible patients with uncomplicated GERD. Acknowledgments The authors thank Dr. William B. Robb for revision of the English language content and the anesthetic team for its involvement in conducting day-case protocols. Authors contributions Study conception and design: Mariette. Acquisition of data: Boutillier, Piessen, Gronnier, Desbeaux. Analysis and interpretation of data: Gronnier, Boutillier, Mariette. Drafting of manuscript: Gronnier, Mariette. Critical revision: Triboulet, Mariette. Disclosures Drs. Gronnier, Desbeaux, Piessen, Boutillier, Ruolt, Triboulet, and Mariette have no conflicts of interest or financial ties to disclose. Conflict of interest
The authors declare no conflicts of interest.
References 1. Dallemagne B, Weerts JM, Jehaes C, Markiewicz S, Lombard R (1991) Laparoscopic Nissen fundoplication: preliminary report. Surg Laparosc Endosc 1:138–143 2. Mariette C, Mabrut JY (2005) Laparoscopic fundoplication: current data. J Chir (Paris) 142:278–283 3. Salminen P, Hurme S, Ovaska J (2012) Fifteen-year outcome of laparoscopic and open Nissen fundoplication: a randomized clinical trial. Ann Thorac Surg 93:228–233 4. Trondsen E, Mjaˆland O, Raeder J, Buanes T (2000) Day-case laparoscopic fundoplication for gastro-oesophageal reflux disease. Br J Surg 87:1708–1711 5. Milford MA, Paluch TA (1997) Ambulatory laparoscopic fundoplication. Surg Endosc 11:1150–1152 6. Bailey ME, Garrett WV, Nisar A, Boyle NH, Slater GH (2003) Day-case laparoscopic Nissen fundoplication. Br J Surg 90:560–562 7. Mariette C, Piessen G, Balon JM, Guidat A, Lebuffe G, Triboulet JP (2007) The safety of the same-day discharge for selected patients after laparoscopic fundoplication: a prospective cohort study. Am J Surg 194:279–282 8. Rijnhart-De Jong HG, Draaisma WA, Smout AJ, Broeders IA, Gooszen HG (2008) The Visick score: a good measure for the overall effect of antireflux surgery? Scand J Gastroenterol 43:787–793 9. Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmu¨lling C, Neugebauer E, Troidl H (1995) Gastrointestinal quality of life index: development, validation and application of a new instrument. Br J Surg 82:216–222 10. Caisse Nationale d’Assurance Maladie des Travailleurs Salarie’s (CNMATS): common classification of medical procedures (2013). http:// www.ameli.fr/fileadmin/user_upload/documents/CCAM_V31.pdf
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Surg Endosc 11. Fenton-Lee D, Riach E, Cooke TG (1995) Day surgery and gastroenterology. Gut 36:324–326 12. McLemore T, Lawrence L (1997) Plan and operation of the national survey of ambulatory surgery. National Center for Health Statistics. Vital Health Stat 37:1–124 13. Kelly ME, Gallagher TK, Smith MJ, Ridgway PF, Conlon KC (2012) Day-case laparoscopic Nissen fundoplication: a default pathway or is selection the key? J Laparoendosc Adv Surg Tech A 22:859–863 14. Khan SA, Stephens L (2012) Day-case laparoscopic Nissen fundoplication. JSLS 16:50–54 15. Mariette C, Pessaux P (2011) Ambulatory laparoscopic fundoplication for gastroesophageal reflux disease: a systematic review. Surg Endosc 25:2859–2864 16. Coelho JC, Wiederkehr JC, Campos AC, Andrigueto PC (1999) Conversions and complications of laparoscopic treatment of gastroesophageal reflux disease. J Am Coll Surg 189:356–361
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17. Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N, IMPACT Investigators (2004) A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med 350:2441–2451 18. Khatri K, Sajid MS, Brodrick R, Baig MK, Sayegh M, Singh KK (2012) Laparoscopic Nissen fundoplication with or without short gastric vessel division: a meta-analysis. Surg Endosc 26:970–978 19. Markar SR, Karthikesalingam AP, Wagner OJ, Jackson D, Hewes JC, Vyas S, Hashemi M (2011) Systematic review and metaanalysis of laparoscopic Nissen fundoplication with or without division of the short gastric vessels. Br J Surg 98:1056–1062
and Other Interventional Techniques
Day-case versus inpatient laparoscopic fundoplication: outcomes, quality of life and cost-analysis C. Gronnier • A. Desbeaux • G. Piessen J. Boutillier • N. Ruolt • J. P. Triboulet C. Mariette
• •
Received: 7 October 2013 / Accepted: 13 January 2014 Ó Springer Science+Business Media New York 2014
Abstract Background Day-case laparoscopic Nissen-Rossetti fundoplication (LF) has been demonstrated to be safe in small, prospective cohorts. The purpose of the study was to compare postoperative course, functional results, quality of life, and healthcare costs in patients undergoing LF in a day-case surgical unit with same-day discharge and patients undergoing LF as an inpatient. Methods All consecutive patients in our department who underwent a primary LF for symptomatic uncomplicated gastroesophageal reflux disease from 2004 to 2011 were entered into a prospective database (n = 292). From 101 same-day discharge patients (day-case group), control
C. Gronnier A. Desbeaux G. Piessen J. Boutillier N. Ruolt J. P. Triboulet C. Mariette (&) Department of Digestive and Oncological Surgery, University Hospital Claude Huriez, Centre Hospitalier Re´gional Universitaire, Place de Verdun, 59037 Lille cedex, France e-mail: [email protected] C. Gronnier e-mail: [email protected] C. Gronnier A. Desbeaux G. Piessen J. Boutillier N. Ruolt J. P. Triboulet C. Mariette Ambulatory Department, University Hospital Claude Huriez, Centre Hospitalier Re´gional Universitaire, Place de Verdun, 59037 Lille cedex, France C. Gronnier G. Piessen J. Boutillier J. P. Triboulet C. Mariette University Lille Nord de France, Place de Verdun, 59045 Lille cedex, France C. Gronnier G. Piessen C. Mariette Inserm UMR 837, Team 5 ‘‘Mucins, Epithelial Differentiation and Carcinogenesis’’, JPARC, Rue Polonovski, 59045 Lille cedex, France
inpatient procedures were randomly matched by age, gender, body mass index, American Society of Anesthesiologists classification, and presence of a hiatal hernia (inpatient group, n = 101). Results No postoperative deaths occurred and postoperative morbidity occurred in 9.4 % of patients. When comparing day-case and inpatient groups, postoperative morbidity rates were 9.9 vs. 8.9 % (p = 0.81) with median hospital stays and readmission rates of 1 vs. 4 days (p \ 0.001) and 7.9 vs. 0 % (p \ 0.001), respectively. Gastrointestinal Quality of Life Index was significantly enhanced due to surgery (p \ 0.001) and comparable in the two groups. Estimated direct healthcare costs per patient were 2,248 euros in the day-case group vs. 6,569 euros in the inpatient group (p \ 0.001), equivalent to a cost saving of 3,921 euros. Conclusions Day-case and inpatient approaches after LF give similar results in terms of postoperative mortality and morbidity, functional outcomes and quality of life, with a substantial cost saving in favor of a day-case procedure. Keywords Laparoscopic fundoplication Reflux Day-case surgery Functional results Quality of life Medico-economic analysis
Day-case surgery has developed over the past three decades for numerous reasons, which include improvements in surgical instruments, the development of minimally invasive techniques, improvement in anesthesia with better control of postoperative nausea and postoperative pain, and specially trained daycare teams. The necessity to reduce healthcare costs and waiting lists also has been a driving force behind this change in practice. Following the first report in 1991 [1], laparoscopic fundoplication (LF) has
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become the surgical approach of choice for gastroesophageal reflux disease (GERD), because it reduces patient length of stay, is associated with better pain control, and facilitates a more rapid postoperative recovery compared with the open approach [2, 3]. Given these benefits of LF, we and others, in small prospective cohorts, have reported the feasibility and the safety of day-case LF in motivated and fit patients [4–7]. Before considering day-case surgery as the standard procedure, postoperative course, functional results, and quality of life should be evaluated and compared with the conventional inpatient procedure. To our knowledge, to date such an evaluation has not been reported. The objective of our study was to test the hypothesis that day-case and inpatient LF for GERD give comparable results but with substantial cost differences. We compare, through a matched case–control study, 30-day postoperative morbidity and mortality, functional results, health-related quality of life (HRQOL), and direct healthcare costs of day-case and inpatient LF.
Patients and methods Data were collected prospectively for all consecutive patients benefiting from a primary Nissen-Rossetti fundoplication for symptomatic uncomplicated GERD between January 2004 and October 2011. The French North-West Ethical Committee approved the study on July 10, 2008. Eligibility criteria were defined according to published literature and day-case requirements to minimize intraoperative complications and/or conversions. Patients considered for day-case LF included patients with GERD without a large hiatal hernia or prior upper abdominal surgery, an American Society of Anesthesiologists (ASA) grade I or II, with good understanding of the care protocol, living within a 1 h drive from hospital, and those who would have adult company at home until the morning after discharge. Patients were not considered for a day-case procedure if living more than a 1 h drive from hospital, they refused an operation as a day-case, or they lived alone at home. Other exclusion criteria from day-case surgery included comorbidities precluding day-case surgery; such conditions included diabetes, coronary artery disease, epilepsy, chronic pulmonary disease, and morbid obesity (body mass index (BMI) [ 40 kg/m2). Day-case patients were matched according to age (±5 years), gender, BMI (±5 kg/m2), ASA score, and presence of a hiatal hernia to control patients with the same characteristics who underwent LF as an inpatient. Patients who had had previous abdominal surgery, an ASA score of III or IV, had a large hiatal hernia, and/or complicated GERD were excluded from the study.
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Preoperative workup All patients benefited from preoperative surgical and anesthetic consultations. Upper digestive endoscopy was routinely performed to identify complications of GERD and/or large hiatal hernias ([5 cm). Esophageal motility was routinely assessed by preoperative esophageal manometry. A 24 h pH-metry was performed in cases of non typical clinical symptoms of GERD. When surgical treatment was discussed, patients were informed about the surgical procedure, expected postoperative course, and possible postoperative problems and complications. The information also was provided on a detailed information sheet, and all patients gave written informed consent. Preoperative management In the day-case group, the perioperative management followed a detailed therapeutic protocol, as described previously [7]. A phone call was performed the day before surgery and the day after surgery as a reminder and to answer potential questions. On the day of the operation, patients arrived at 7:30 a.m., and the intervention started at 9:00 a.m. In the inpatient group, patients were admitted the day before surgery and the operation was performed the following morning. Surgical approach A laparoscopic Nissen-Rossetti, without division of the short gastric vessels and with sutured crural closure, was performed in all patients. Major intraoperative events, such as intraoperative blood loss requiring transfusion, esophageal injury, or conversion to laparotomy were contraindications to same day discharge. Long-acting local anesthetic was systematically placed under the diaphragm (2 9 15 ml of bupivacaine 2.5 mg/ml) and 10 ml of the same product was infiltrated into the wounds at the end of the procedure in all patients. A nasogastric tube of 21-French was routinely used to help calibrate the valve and was removed before extubation. Postoperative management Day-case group Postoperative pain was managed by i.v. paracetamol (1 g) administered 30 min before the end of surgery. In addition, i.v. ketoprofen (100 mg) and tramadol (100 mg) could be administered in the recovery room if the patient’s pain score was greater than 4, estimated by a 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain). In order to prevent postoperative nausea and
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vomiting (PONV), patients systematically received intravenous ondansetron 4 mg. All patients were given oral fluids and soft solids after transfer from the recovery room to the postoperative observation unit with early mobilization. Patients were scheduled to leave before 6:00 p.m. If deemed unsuitable for discharge, they were admitted for an overnight stay. Before departure, systematic chest x-ray and hemoglobin measurement were performed, and patients were examined by both the responsible surgeon and the anesthetist in charge of the operation. They were given a standard package of analgesics on discharge consisting of tramadol (100 mg three times daily), paracetamol (1 g three times daily), a nonsteroidal anti-inflammatory (100 mg twice daily), and metoclopramide (10 suppositories) for 5 days. Information regarding what postoperative symptoms may be expected was repeated, and an information leaflet also was given to both patients and relatives. This included relevant contact telephone numbers. Patients were routinely contacted by the surgeon the next day and were seen in consultation after 5 days, 3 months, 6 months, and annually thereafter.
(range 0–144). It measures specific and general HRQoL by including measures of overall HRQoL. Five dimensions of HRQoL were evaluated: (1) symptoms (0–76 points), (2) physical condition (0–28 points), (3) feelings (0–20 points), (4) social integration (0–16 points), and (5) medical treatment (0–4 points). The higher the score on the GIQLI, the better the HRQoL is. An estimate of direct perioperative costs was performed, based on costs fixed by our institution and the CNAMTS (French national health insurance) [10]. Were considered costs related to surgical consultation (26 euros) with one preoperative and one postoperative consultation, anesthetic consultation (26 euros), conventional hospitalization (1,554 euros ? 18 euros—unit cost for each day of hospitalization), unit cost for a single day-case bed (832 euros), standard hospital operation costs (397.5 euros), standard cost for a converted surgical procedure (322.6 euros), reoperation by laparoscopy (397.5 euros) or by laparotomy (322.6 euros), any additional consultation (26 euros), and cost of hospital readmission (1,554 euros ? 18 euros of daily unit cost for each day of hospitalization). Statistical analysis
Inpatient group Patients systematically remained in the hospital for at least one night following surgery. Systematic postoperative chest x-ray and hemoglobin measurement were performed, and patients were given oral fluids and soft diet on the same day of surgery, as permitted by the presence or absence of PONV. The responsible surgeon discharged the patient usually 1 or 2 days after surgery after clinical examination, optimal management of both pain and PONV, with a soft diet recommended for 3 weeks. Patients were routinely seen in consultation after 3 months, 6 months, and annually thereafter.
Median follow-up was 62 months [5–109]. Two patients were lost to follow-up, one in each group. Data were collected in a prospective database and analyzed in intent to treat, using SPSSÒ version 15.0 software (SPSS, Chicago, IL). Data were presented as prevalence, means (standard deviation), or median (range). Continuous data were compared by means of the Mann–Whitney U test and ordinal data by the Chi square test or Fisher exact test as appropriate. P \ 0.05 was considered statistically significant.
Results Parameters studied Demographic and preoperative data All peri- and postoperative data were recorded in intent to treat by independent observers (JB and GP). In addition to per- and postoperative courses, dedicated endpoints for daycase patients were recorded, including hospital admissions, nonscheduled consultations, or hospital readmission. Functional results were evaluated at 3 (±1) months and 24 (±6) months, taking into account recurrence of GERD symptoms, need for antireflux medication, dysphagia, gas bloat syndrome, and the performance of any further invasive procedures. The Visick validated scoring system was used to evaluate patients’ satisfaction [8]. Quality of life was evaluated before and after surgery using the Gastrointestinal Quality of Life Index (GIQLI) [9]. The GIQLI contains up to 36 items scored on a 5-point Likert scale
Between January 2004 and October 2011, a LF was performed in 292 consecutive patients. All day-case patients (n = 101) were compared to comparable patients undergoing surgery as an inpatient after matching by age, gender, BMI, ASA score, and presence of a hiatal hernia (n = 101; Table 1). In the study population (n = 202), 116 patients were men (57.4 %), with an ASA score of I (70.8 %) or II (29.2 %). The median age was of 39.4 years [16–72] and the median BMI was 26.0 kg/m2 [17–48]. As expected, the day-case and the inpatient control groups had comparable demographic data (Table 1). The median duration of the intervention was 79 min [32–176] in the day-case group
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Surg Endosc Table 1 Preoperative, peroperative, and postoperative data
Median age [range] (year)
Day-case group N = 101 (50 %)
Control group N = 101 (50 %)
p value
37.4 [15.6–64.1]
41.1 [15.7–72.0]
0.346
ASA score ASA 1 (%) ASA 2 (%)
Table 2 Patients’ satisfaction according to Visick classification
0.877 71 (70. 3 %) 30 (29.7 %)
72 (71.3 %) 29 (28.7 %)
Gender
0.393
Male (%)
61 (60.4 %)
55 (54.4 %)
Female (%)
40 (39.6 %)
46 (45.6 %)
Hiatal hernia
Day-case group N = 101 (50 %)
Control group (%) N = 101 (50 %)
Total N = 202 (100 %)
p value
Visick 1
68 (67.3 %)
67 (66.3 %)
135 (66.8 %)
0.155
Visick 2
21 (20.8 %)
22 (21.8 %)
43 (21.3 %)
At 3 months
Visick 3
3 (3 %)
3 (3 %)
Visick 4
9 (8.9 %)
9 (8.9 %)
18 (8.9 %)
6 (3 %)
Visick 1
58 (57.4 %)
58 (57.4 %)
116 (57.4 %)
Visick 2
20 (19.8 %)
20 (19.8 %)
40 (19.8 %)
At 24 months
0.826
Yes
46 (45.5 %)
45 (44.6 %)
Visick 3
13 (12.9 %)
13 (12.9 %)
26 (12.9 %)
No
55 (54.5 %)
56 (55.4 %)
Visick 4
10 (9.9 %)
10 (9.9 %)
20 (9.9 %)
Median BMI [range] (kg/m2)
25.3 [16.4–38.0]
26.5 [18.8–47.8]
0.437
Median operative time [range] (min)
73 [35–176]
85 [32–166]
0.069
Postoperative morbidity (%)
10 (9.9 %)
9 (8.9 %)
0.81
ASA American Society of Anesthesiologists, BMI body mass index
(73 min [35–176] vs. 85 min [32–166] in the inpatient group, respectively; p = 0.069). Neither patients suffered peroperative complications nor conversion to laparotomy. Thirty-day postoperative course There were no postoperative deaths. The overall 30-day postoperative morbidity rate was 9.4 % (n = 19), 9.9 % (n = 10) in the day-case group, and 8.9 % (n = 9) in the inpatient group (p = 0.81; Table 1). Surgical complications in the day-case group were intrathoracic migration of the fundoplication following uncontrolled and prolonged vomiting (n = 1), severe dysphagia (n = 6), medical treatment of a superficial abscess (n = 3) and, in the inpatient group, severe dysphagia (n = 5) and prolonged nausea (n = 1). No medical complications were noted in the day-case group, whereas acute urinary retention (n = 1), thrombophlebitis (n = 1), and a cutaneous iodine reaction (n = 1) were reported in the inpatient group. Regarding outpatient endpoints in the day-case group, 79 patients (78.2 %) were discharged after operation as planned before 6:00 p.m. Twenty-two patients failed to meet discharge criteria and were admitted directly from the day ward (21.8 %) [dysphagia (n = 4), vasovagal syncope (n = 2), inadequate pain control (n = 4), PONV (n = 9), and anxiety (n = 3)]. Among these patients, 15 (68.2 %) returned home within 24 h after their operation. The median length of stay was 1 day [1–7] in the daycase group versus 4 days [2–10] in the inpatient group
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0.771
(p \ 0.001), with a median length of stay after the surgical procedure of 0 days [0–7] vs. 2 days [1–8], respectively (p \ 0.001). The median delay to recommencing diet was 0 days [0–1] and 1 day [0–3] in the day-case and inpatient groups respectively (p \ 0.001). Unscheduled consultations within 30 postoperative days were reported in seven patients in the day-case group (6.9 %) and three in the inpatient group (3 %, p = 0.194). This was due to dysphagia in five patients in the day-case group and one in the inpatient group, and epigastric pain in two patients in each group. Unscheduled readmissions within 30 days of surgery were reported in eight patients (7.9 %) exclusively in the day-case group, including severe dysphagia requiring reoperation (n = 3), pyrexia related to bronchitis (n = 1), wound abscess (n = 1), and vomiting (n = 3). Functional results At 3 months, 88.1 % of patients (n = 178) had excellent to very good results (Visick 1 and 2), 3 % (n = 6) had acceptable results (Visick 3), and 8.9 % (n = 18) had unsatisfying results (Visick 4). At 24 months, minor changes to patient satisfaction ratings were noted with 77.2 % (n = 156) Visick 1 and 2, 12.9 % (n = 26) Visick 3, and 9.9 % (n = 20) Visick 4 (Table 2). No significant differences in satisfaction ratings were observed between day-case and inpatient groups at either time point. With regards to control of symptoms of GERD, 8.9 % of patients (n = 18) reported some GERD symptoms at 3 months: 7.6 % (n = 8) in the day-case group vs. 9.9 % (n = 10) in the inpatient group (p = 0.395). At 24 months, 20.3 % of patients (n = 41) reported some symptoms of GERD: 20.8 % (n = 21) in the day-case group vs. 19.8 % (n = 20) in the inpatient group (p = 0.501). Seven patients (3.5 %) were reoperated on for recurrence of symptoms of
Surg Endosc Table 3 Quality of life evaluation according to the GIQLI score Day-case group (mean ± SD)
Control group (mean ± SD)
Total (mean ± SD)
p value
Total 89.2 (±24.8)
81.8 (± 26.2)
Postoperative score after 3 months
Preoperative score
112.5 (±20.1)
101.7 (± 22.6)
Postoperative score after 24 months
94.6 (±24.6)
98.2 (± 24.5)
86.4 (±25.4) 108.2 (±22) 97.2 (±24.8)
0.778 0.348 0.499
Symptoms Preoperative score
48.1 (±11.7)
44.5 (± 11.3)
46.4 (±11.7)
0.667
Postoperative score after 3 months
56.9 (±11.3)
52.3 (± 11.9)
53.8 (±14)
0.501
Postoperative score after 24 months
49.0 (±11.6)
49.1 (± 14.6)
49.0 (±12)
0.264
Physical condition Preoperative score
15.0 (±7.2)
13.6 (± 8.2)
14.3 (±7.7)
0.309
Postoperative score after 3 months Postoperative score after 24 months
21.3 (±5.2) 16.0 (±6.9)
18.8 (± 5.9) 17.5 (± 8)
19.9 (±6.2) 16.5 (±7.1)
0.988 0.521
11.9 (±4.6)
10.7 (±4.7)
11.4 (±5.2)
0.055
Emotion Preoperative score Postoperative score after 3 months
16.8 (±4.2)
14.6 (±5)
15.6 (±5)
0.858
Postoperative score after 24 months
13.7 (±4.9)
13.6 (±3.9)
13.6 (±3.5)
0.129
Social integration Preoperative score
11.3 (±4)
10.7 (±4.1)
11.0 (±4.1)
0.19
Postoperative score after 3 months
14.0 (±3)
12.6 (±3.8)
13.2 (±3.8)
0.373
Postoperative score after 24 months
12.5 (±3.6)
12.9 (±2.6)
12.6 (±2.5)
0.209
Medical treatment Preoperative score
2.9 (±1.4)
2.4 (±1.5)
2.7 (±1.5)
0.226
Postoperative score after 3 months
3.6 (±1)
3.4 (±1.3)
3.5 (±1.2)
0.656
Postoperative score after 24 months
3.4 (±1)
3.8 (±0.7)
3.6 (±0.5)
0.217
SD standard deviation, GIQLI gastrointestinal quality of life index
GERD: three in the day-case group (3 %) and four in the inpatient group (3.9 %; p = 0.544). Severe dysphagia was reported in 3.9 % of patients at 3 months (n = 8): 3.9 % in the day-case group (n = 4) and 3.9 % in the inpatient group (n = 4; p = 1.000). At 24 months, the overall dysphagia rate was 17.8 % (n = 38), 17.8 % in the day-case group (n = 18), and 17.8 % in the inpatient group (n = 18; p = 1.000). During the study period, reoperation for severe dysphagia was required in 2 % of cases (n = 4): 1 % (n = 1) vs. 3 % (n = 3) in the day-case and the inpatient groups respectively (p = 0.73). Symptoms related to gas bloat syndrome were reported in 4.5 % of patients (n = 9) at 3 months: 5.9 % (n = 6) and 3 % (n = 3) in the day-case and inpatient groups respectively (p = 0.239). At 24 months, the overall rate of gas bloat symptoms was 17.3 % (n = 35): 16.8 % (n = 17) and 17.8 % (n = 18) in the day-case and inpatient groups, respectively (p = 0.775). During the study period, the reoperation rate was 11.4 % (n = 23), with 12 patients (11.9 %) reoperated on in the day-case group and 11 (10.9 %) in the inpatient group (p = 0.618). Fifty percent of reoperations were performed
within the first 6 months following the primary procedure. Indications for reoperation included severe dysphagia (n = 10, 4.9 %), recurrence of GERD symptoms (n = 12, 5.9 %), and fundoplication migration (n = 1, 0.5 %). All reoperations except one were performed laparoscopically. Health-related quality of life Compared with the preoperative setting, the GIQLI was significantly improved for the global score at 3 months (86 ± 25 vs. 108 ± 22, p \ 0.001) and at 24 months (86 ± 25 vs. 97 ± 24, p \ 0.001) after surgery and also in each of the dimensions evaluated; symptoms, physical condition, feelings, social integration, and medical treatment (p \ 0.001; Table 3). There were no significant differences between the day-case and the inpatient groups regarding global scoring or any of the individual dimensions evaluated. Direct healthcare costs evaluation The 101 patients in the day-case group represented a total cost of 227,039 euros, giving a mean cost of 2,248 euros
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Surg Endosc Table 4 Direct healthcare costs estimation
Unit cost (euros) Number of patients
Day-case group
Control group
n
n
Total costs (euros)
101
Total costs (euros)
101
Preoperative surgical consultation
26
101
2,626
101
2,626
Preoperative anesthesia consultation
26
101
2,626
101
2,626
Days of conventional hospitalization
1,554
63
97,902
417
648,018
Daily fixed cost for each day of hospitalization
18
142
2,556
417
7,506
Days of hospitalization in ambulatory sector
832
79
65,728
0
0
Laparoscopic fundoplication Conversion
397.5 322.63
101 0
40,147.5 0
101 0
40,147.5 0
Postoperative surgical consultation
26
112
2,912
104
2,704
Hospital readmission
8
0
Days of conventional hospitalization
1,554
32
49,728
0
0
Daily fixed cost for each day of hospitalization
18
32
576
0
0
Laparoscopic redo surgery
397.5
6
2,385
0
0
Redo surgery by laparotomy
322.63
1
322.6
0
0
Total cost
227,039
663,480
Mean cost by patient
2,248
6569a
a
p \ 0.001
per patient (Table 4). In the inpatient group, the total cost was 663,480 euros for 101 patients, giving a mean cost of 6,569 euros per patient (p \ 0.001). In other words, daycase surgery was responsible for a cost saving of 3,921 euros. Considering that some centers worldwide may propose a hospitalization the morning of surgery, we also evaluated adjusted costs that were 5,015 euros in the inpatient group without the cost of the day before surgery significantly higher than in the day-case group (p \ 0.001), for a remaining saving cost of 2,367 euros.
Discussion Since the beginning of this century, day-case surgery has been performed for both its patient and economic benefits [11]. Day-case surgery accounts for approximately 94 % of eligible surgical procedures in the United States, 78 % in Denmark, 67 % in Holland, 60 % in the United Kingdom, and for only 30 % in France [12]. Improved surgical and anesthetic techniques, as well as cost considerations, means this low rate of day-case surgery is expected to increase significantly with an expansion in the array of procedures, which are deemed eligible. A few recent publications, of retrospectives studies [13, 14] and small prospective cohorts [4–7], have reported the feasibility and safety of day-case LF in motivated and fit patients. These studies were pooled in a recent systematic review [15], but none of them have comparatively evaluated day-case and inpatient
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procedures in terms of postoperative course, functional results, HRQoL, and cost savings. Such an analysis was the goal of the present work. Our study confirms the feasibility of LF in the day-case setting with no postoperative mortality, a low rate of postoperative morbidity (9.4 %), a failure of same day discharge in 21.8 % and nonscheduled consultation and readmission rates of 6.9 and 7.9 %, respectively. Significant morbidity was related to dysphagia in six cases, treated by reoperation, with one serious complication at the beginning of our experience in a patient who suffered intrathoracic migration of the fundoplication following uncontrolled PONV on the day of surgery requiring reoperation with an eventful postoperative course. This patient failed same-day discharge being discharged after one night in the hospital. Such early intrathoracic fundoplication migration also has been described in inpatient series [16]. This complication does not preclude the feasibility of a LF day-case program, but highlights the fact that patients can only be discharged from hospital after strict control of PONV, facilitated by an avoidance of opioids and the use of prophylactic antiemetic protocols adjusted to the Apfel’s 4-item risk score [7–12, 16, 17]. The originality of this work is in showing that functional results and HRQoL after LF are similar for patients treated in a day-case and conventional inpatient setting. In other words, a day-case approach does not impact negatively on the quality of surgical results. It is of importance to underline that day-case surgery is not detrimental to the
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emotional dimension of HRQoL, as it could be hypothesized that significantly decreasing the duration of hospitalization could lead to enhanced patient anxiety. Even if HRQoL is significantly improved by surgery and the results are consistently comparable between the two groups over time, a slight deterioration of the functional results with time is evident. A constant proportion of patients experienced poor functional results regardless of the time point of follow-up (Visick 4 score of 8.9 % at 3 months and 9.9 % at 24 months), mainly related to recurrence of the symptoms of GERD or dysphagia, and probably due to inappropriate patient selection for surgery. A further group of patients will observe slight deterioration of their results with time, reflected by the Visick 3 score growing from 3 % at 3 months to 12.9 % at 24 months, independently of the treatment group. Whilst postoperative mortality is very uncommon in published series (0 % in the present series), postoperative complications, such as dysphagia or gas bloat syndrome, have been frequently reported [18, 19] with respective rates of 17.8 and 17.3 % in our study. There are many advantages of day-case surgery compared with traditional inpatient surgery. These include convenience (the convenience of recovering at home generally makes recovery time quicker and easier than an inhospital stay), decreased prescription of medications, reduced stress, and increased rates of scheduled surgery due to more efficient use of hospital and surgeon’s time. However, the main advantage of the day-case setting is probably financial, and the present study, even allowing for the fact that the cost-analysis has been grossly conducted, exhibits a mean saving cost of 3,921 euros per patient treated. This amount represents approximately 50 % of the direct costs linked to an inpatient LF procedure with 2 days of hospitalization. One can argue than some centers worldwide provide admission the day of surgery and not the day before, leaving also in this situation a cost saving of 2,367 euros. The obvious advantages of day surgery have been already established in countries with a predominantly privately funded healthcare system but remain to be optimized in public hospitals. In digestive surgery, the application of day-case surgery has largely been restricted to hernia repair and cholecystectomy, and hence there is huge potential for its expansion especially for laparoscopic procedures. In selected patients, LF, due to its simplicity and low morbidity, appears to be a good candidate in the drive to expand the number of digestive surgical procedures performed on a day-case basis. A preoperative standardized education program for ambulatory surgery might be useful to better prepare patients for day-case management. This study has some limitations due to its retrospective nature and the fact that some missing data impaired the robustness of HRQoL evaluation. Moreover, having considered only direct and mean costs may have impaired our
cost-analysis, but there are no reasons for thinking that drug medication costs would have modified significantly the results or that having included indirect costs may have linked to opposite results. The matching technique based on numerous and pertinent variables, as well as the inclusion of consecutive and unselected patients and evaluation by independent observers blinded from the treatment group, may have limited the impact of bias on results. A randomized trial with medical and medico-economic endpoints is needed to definitively assert that day-case LF should be the ‘‘gold standard’’ for the surgical treatment of eligible patients with uncomplicated GERD. Acknowledgments The authors thank Dr. William B. Robb for revision of the English language content and the anesthetic team for its involvement in conducting day-case protocols. Authors contributions Study conception and design: Mariette. Acquisition of data: Boutillier, Piessen, Gronnier, Desbeaux. Analysis and interpretation of data: Gronnier, Boutillier, Mariette. Drafting of manuscript: Gronnier, Mariette. Critical revision: Triboulet, Mariette. Disclosures Drs. Gronnier, Desbeaux, Piessen, Boutillier, Ruolt, Triboulet, and Mariette have no conflicts of interest or financial ties to disclose. Conflict of interest
The authors declare no conflicts of interest.
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