Journal of Investigative Surgery, 27, 234–239, 2014 C 2014 Informa Healthcare USA, Inc. Copyright ISSN: 0894-1939 print / 1521-0553 online DOI: 10.3109/08941939.2013.875606
SURGICAL TECHNIQUES
Is Nasogastric Decompression Useful in Prevention of Leaks After Laparoscopic Sleeve Gastrectomy? A Randomized Trial
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Gianluca Rossetti, MD,1 Landino Fei,1 Ludovico Docimo,2 Gianmattia Del Genio,2 Fausta Micanti,1 Annamaria Belfiore,1 Luigi Brusciano,2 Francesco Moccia,1 Marco Cimmino,1 Teresa Marra1 1
Digestive Surgery Unit, Second University of Naples, via Pansini 5, Naples, Italy, 2 Unit of Obesity Surgery, Second University of Naples, via Pansini 5, Naples, Italy
ABSTRACT Introduction: Although its excellent results, laparoscopic sleeve gastrectomy (LSG) presents major complications ranging from 0% to 29%. Among them, the staple line leak presents an incidence varying from 0% to 7%. Many trials debated about different solutions in order to reduce leaks’ incidence. No author has investigated the role of gastric decompression in the prevention of this complication. Aim of our work is to evaluate if this procedure can play a role in avoiding the occurrence of staple line leaks after LSG. Materials and Methods: Between January 2008 and November 2012, 145 patients were prospectively and randomly included in the study. Seventy patients composed the group A, whose operations were completed with placement of nasogastric tube; the other 75 patients were included in the group B, in which no nasogastric tube was placed. Results: No statistical differences were observed between group A and group B regarding gender distribution, age, weight, and BMI. No intraoperative complications and no conversion occurred in both groups. Intraoperative blood loss (50.1 ± 42.3 vs. 52.5 ± 37.6 ml, respectively) and operative time (65.4 ± 25.5 vs. 62.6 ± 27.8 min, respectively) were comparable between the two groups (p: NS). One staple line leak (1.4%) occurred on 6th postoperative day in group A patients. No leak was observed in group B patients. Postoperative hospital stay was significantly longer in group A vs. group B patients (7.6 ± 3.4 vs. 6.2 ± 3.1 days, respectively, p: 0.04). Conclusions: Routine placement of nasogastric tube in patients operated of LSG seems not useful in reducing leaks’ incidence. Keywords: Bariatric surgery; sleeve gastrectomy; laparoscopy; staple line leak; nasogastric tube
INTRODUCTION
trectomy (LSG) is becoming a popular restrictive procedure [5–9]. It has quickly attracted surgical interest because it does not require gastrointestinal anastomosis nor the use of a foreign material (gastric band) and it is considered less technically challenging than other bariatric interventions [10–12]. Many authors support LSG as a first step in high-risk patients and in those with a high BMI, with the aim of performing a second final procedure after an acceptable degree of weight loss to reduce surgical risk. However, now LSG is increasingly being accepted as a valid stand-alone procedure for the surgical treatment of obesity as it is effective in achieving 60%–70% excess weight loss at a follow up of almost three years [13], comparable with
Obesity represents a worldwide epidemic and has become a major medical and social problem of western countries. In 2025, 40% of US population will be obese according to current alimentary trends [1]. For patients with morbid obesity (obesity class II or III), surgical management remains the only evidence-based approach to achieve relevant long-term weight loss [2, 3]. A minimally invasive approach to the surgical management of obesity has been shown to dramatically reduce perioperative morbidity through reduced blood loss, hospital stay and wound complications [4]. Among the different surgical procedures, laparoscopic sleeve gasReceived 7 October 2013; accepted 11 December 2013.
Address correspondence to Dr Gianluca Rossetti, MD, Digestive Surgery Unit, Second University of Naples, via Pansini 5, Naples 80131, Italy. E-mail: [email protected]
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Sleeve Gastrectomy Leaks Prevention other bariatric procedures [14–17]. Despite these excellent results, LSG is not free from significant morbidity. In a recent review, the mortality rate was 0–3.3%, while major complications (bleeding, abscess, leak) ranged from 0% to 29% (average 12%) [13]. Among them, the staple line leak is the most fearful with a varying incidence from 0% to 7% [13, 18– 23]. Many trials have been published debating about the role of reinforcement of the suture staple line in order to reduce leaks’ incidence [24–28], but no definitive conclusion can be drawn on the argument. Instead, at our knowledge, no author has investigated the possible role of gastric decompression in the prevention of this complication. Aim of our work is to evaluate, in a randomized controlled trial, if this procedure can play a role in avoiding the occurrence of suture staple line leaks after LSG.
TABLE 1
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Patients characteristics
Characteristics Gender (n) Female Male Age (years) Mean ± SD Range Weight (Kg) Mean ± SD Range BMI (kg/m2 ) Mean ± SD Range BMI>50 Hypertension Diabetes Sleep apnea
Group A
Group B
P
39 (55.7%) 31 (44.3%)
40 (53.3%) 35 (46.7%)
0.22(NS)
33.8 ± 7.4 21–58
36.9 ± 8.7 19–59
0.13(NS)
132.1 ± 18.3 105–185
137.6 ± 21.2 100–190
0.11(NS)
46.4 ± 6.3 42–58.3 15 (21.4%) 22 (31.4%) 16 (22.9%) 7 (10.0%)
48.1 ± 7.1 40–57.9 18 (25.3%) 20 (26.6%) 18 (24.0%) 8 (10.7%)
0.24(NS) 0.31(NS) 0.15(NS) 0.28(NS) 0.18(NS)
MATERIALS AND METHODS Between January 2008 and November 2012, 209 patients affected with morbid obesity came to our observation. Of these, 145 were prospectively and randomly included in the study approved by the ethics committee: 70 patients composed the group A whose operations were completed with the placement of a nasogastric tube; the other 75 patients were included in the group B in which no nasogastric tube was placed at the end of the intervention. All the operations were performed by the same operative team. Inclusion criteria were a body mass index (BMI) greater than 40 kg/m2 or greater than 35 kg/m2 associated with relevant comorbidities. Exclusion criteria were the inability to undergo general anesthesia, age greater than 60 years and BMI > 60. Patients were addressed to LSG after a multidisciplinary team evaluation including a surgical, psychiatric, nutritional, and endocrinological visit. Preoperative investigations included the following: complete blood laboratory examens, electrocardiogram and cardiologic visit, chest X-ray and pulmonary function test, gastroscopy, and abdominal ultrasound. In case of grade I esophagitis and/or hiatal hernia >3 cm, the patients were addressed to Roux-en-y gastric bypass. The following co-morbidities were present in the two groups: arterial hypertension in 22 patients, type II diabetes in 16 patients, and sleep apnea in 7 patients in group A, while they were respectively observed in 20, 18, and 8 patients in group B (Table 1).
Statistical Analysis Quantitative data were expressed as mean or range. Statistical analysis was performed using the chi-square test (Pearson, Mantel–Haenzel test for linear association) with the Yate’s correction or the Fisher’s exact test and Mann–Whitney U-test whenever needed. The pvalue was considered statistically significant when be C
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low 0.05. The statistical package used was SPSS 16.0 (SPSS Inc., Chicago, IL).
Surgical Technique All the operations were conducted under general anesthesia. Induction was carried out with midazolam 0.3 mg/kg, propofol 1.5 mg/kg, and rocuronium 0.9 mg/kg intravenous (IV) for tracheal intubation. The maintenance was performed with remifentanil 0.15–0.25 μg/kg/min, isoflurane 1% mixture of oxygen and air 1:1, and additional dose of rocuronium if necessary. At the induction, a single dose of IV third generation cephalosporine was administered for a short-term antibiotic prophylaxis. The patient was placed in a lithotomic and reverse Trendelenburg position with sequential compression of lower limbs. Operating surgeon was placed between the patient’s legs. After pneumoperitoneum induction at a 15 mmHg value by a Veress needle, five trocars were introduced. The first one was positioned under direct vision with an OptiView trocar (Ethicon Endo-Surgery, Cincinnati, OH). The other four trocars, two 5 mm and two 12 mm, were introduced under direct vision. Dissection of the greater curvature started at almost 6–7 cm from the pylorus and was conducted upwards until the angle of His by means of LigasureTM (Covidien, Mansflield, MA). Attention was paid in mobilizing the entire fundus to the mid-portion of the left crura of the diaphragm. Then, a 36-Fr bougie was inserted by the anesthesiologist into the stomach and directed closely along lesser curvature toward the pylorus. Resection of the antrum started parallel to the bougie from the right lateral port using the Echelon 60 Endopath (Ethicon Endo-Surgery, Cincinnati, OH) with gold cartridge (3.8 mm). After the first two firings, the resection of the body and fundus of the stomach was
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performed using blue cartridges (3.5 mm) via the left mid-clavicular port site to the angle of His. All stapling was performed holding initial compression for a minimum of 15 s between the strokes of the device. We did not mobilize the periesophageal fat pad in order to leave approximately 1 cm of gastric tissue lateral to the angle of His. Routinely, we did not use buttress material neither over-sewed the staple line. Only in case of persistent bleeding, we positioned some interrupted stitches along the suture line. Once the gastric partition had been completed, an upper endoscopy was performed to check the integrity of the suture line: air was insufflated and irrigation was sprayed over the staple line to check for leaks. Resected stomach was extracted from the abdominal cavity through a dilated 12-mm trocar incision in a specimen bag. At the end of operation, a drain was placed alongside the staple line and, in group A patients, a nasogastric tube was inserted in the stomach. The latter was removed generally on 5th postoperative day. Postoperative analgesia was done with intravenous ketorolac 90 mg/die and tramadol 300 mg/die for the first 24 hr. All the patients received in the early postoperative period intravenous hydration and proton pump inhibitors (PPI) at a dose of 40 mg per day until the beginning of oral alimentation. Upper GI X-ray was carried out in all patients on the 5th postoperative day. They were discharged home on the 6th postoperative day with prescription of a 40 mg per day oral PPI therapy for six months. Liquid diet started on 6th postoperative day and was allowed for 10–15 days under strict nutritionist surveillance. All the patients underwent clinical follow-up at three months and six months from the operation.
RESULTS No statistical differences were observed between group A and group B patients regarding gender distribution, age, weight, and BMI as it is reported in Table 1. No intraoperative complications occurred in both groups and all the interventions were completed via laparoscopic approach. No significant differences were observed between the two groups in terms of intraoperative blood loss and operative time, as it is showed in Table 2. Mean output of nasogastric tube was 68 ± 21 ml per day. It consisted mainly of gastric juice. No nausea and vomiting were complained by the patients either in group A or in group B. The following postoperative complications occurred in three patients: two bleedings, one in group A (1.4%) and one in group B (1.3%), and one staple line leak on the 6th postoperative day in group A (1.4%) (Table 2). In all cases, conservative therapy was successful and no reoperation was necessary. The only leak occurred in group A was located 2–3 cm below the gastroesophageal junction: it was treated with total parenteral nutrition and spontaneously healed in 25 days. The differences between
TABLE 2
Perioperative results
Parameters Intraoperative blood loss (ml) Mean ± SD Range Operative time (min) Mean ± SD Range Overall morbidity Leak Hospital stay Mean ± SD Range
Group A
Group B
P value
50.1 ± 42.3 20–250
52.5 ± 37.6 30–220
0.16 (NS)
65.4 ± 25.5 50–120 2 (2.8%) 1 (1.4%)
62.6 ± 27.8 55–130 1 (1.3%) 0 (0%)
0.13 (NS)
7.6 ± 3.4 5–25
6.2 ± 3.1 5–13
0.11 (NS) 0.09 (NS) 0.04
the two groups in terms of overall morbidity and leak incidence were not statistically significant (Table 2). Postoperative hospital stay was significantly longer in group A patients (p < .04) (Table 2). At clinical followup, at three and six months from the operation, no patient, either in group A or group B, presented clinical signs of leak.
DISCUSSION Although LSG is worldwide considered as a successful surgical procedure for morbid obesity, it is not free from significant complications, among which the staple line leak is the most fearful with a varying incidence from 0% to 7% [13, 18–23]. Etiology of leaks can be classified into mechanical and ischemic causes, which include tension, ischemia, poor wound healing, technical errors, inappropriate instrument use, and iatrogenic injury. Ischemic leaks occur generally 5–7 days postoperatively, when wound healing is between the inflammatory and fibrotic phases, whereas the most common causes of leaks that occur within the first 48 hr are mechanical [29]. Aiming to reduce leaks’ incidence, relevant steps include careful tissue management, optimal use of endostaplers, prevention of distal stenosis, and good hemostasis. When using endostaplers, it is considered determining to begin tissue compression carefully and maintain this position for enough time to allow the tissue fluids to exit. Some authors advise waiting for around 10 [30] or 30–60 s [25] after stapler closure before firing: Kasalicky et al. [25] reported no leaks at 18-months follow-up with this technique. Other authors, such as Bellanger et al. [23], suggested avoiding the incorporation of the area of the gastroesophageal junction into the suture line: they observed a 0% leak rate in a series of 529 sleeve gastrectomies performed. However, most authors suggest the use of staple line reinforcement in order to prevent suture line leak. The 2009 international consensus conference on sleeve gastrectomy reported that staple line reinforcement was performed by 65.1% of Journal of Investigative Surgery
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Sleeve Gastrectomy Leaks Prevention the surgeons’ responders: 42.1% used buttressing materials, 50.9% oversewed the staple line, and 7.0% used both methods [6]. Different materials have been used: Seamguard (Gore, Falstaff, AZ, USA), an absorbable polymer membrane constituted of polyglycolic acid (67%) and trimethylene carbonate (33%), is one of the R , most frequently employed. Fibrin sealants (Tissucol R R (PSD, Synovis), Vivostat ) and Peri-Strips Dry segments of dehydrated bovine pericardium, are also used: some studies have reported a decreased leak incidence with these materials [31–34]. Other authors prefer protecting the staple line with a continuous sero-serous suture: in their opinion, this technique is able to reduce the number of leaks as it inverts the staples and controls bleeding [35–37]. However, a recent trial documented no significant difference in terms of postoperative morbidity rates between buttressing staple line with Seamguard and staple line suturing [38]. Moreover, another prospective randomized trial demonstrated that even not performing a staple line reinforcement, results in terms of leak incidence were comparable with the two previous techniques [27]. These results have been confirmed also in a recent review [39]. We agree with the conclusion of these studies as, in our experience, we routinely do not perform any staple line protection: only in case of persistent bleeding, we position some interrupted stitches along the suture line. Our results support this choice: in fact, leak incidence in our series (1/145, 0.6%) is overall comparable with the experiences reported in the literature [13, 18–23]. We consider determining a careful tissue manipulation, an accurate hemostasis and primarily keeping the stapler at a distance of almost 2–3 cm from the angle of His in order to preserve blood supply of the esophagogastric junction; moreover, we always keep in mind to maintain stapler closure for almost 15–20 s before firing, as recommended. Another determining factor for leak occurrence, especially below the gastroesophageal junction, could be depending on the development of high intra-luminal pressure consequential to the long vertical tubulization of the stomach [40, 41]. Yehoshua [41] observed an increased intragastric pressure in the sleeved stomach (mean 43 ± 8 mmHg), whereas mean intragastric pressure in a normal stomach is 34 ± 6 mmHg. This pressure is amplified by the fact that the compliance of the sleeve is ten times less than the complete stomach or the resected fundus [40, 41]. This physical situation could be a determining factor for leaks occurrence, because the thickness of the gastric tissue varies between the antrum, the body, and the fundus (3.1 mm, 2.4 mm, and 1.7 mm, respectively) [42]. For this reason, the gastric tissue at the angle of His could be more prone to leak occurrence. According to this observation, Gagner documented an inverse relationship between bougie size and leak rate and advocates using a bougie size between 50 and 60 French to minimize this complication C
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[43]. This evidence has been confirmed also in a recent review [44]. Since the reduction of intragastric pressure could help in reducing leaks’ incidence, a matter of debate can be represented by the role of nasogastric decompression in the first postoperative days aiming to reduce the mechanical stress on the staple suture line. Most authors, mainly from USA, routinely do not perform nasogastric decompression as they discharge patients on postoperative day 1. Only few surgical teams specifically mention that they place nasogastric tube during the first two postoperative days [20, 26, 37, 45–47]. Usually, they remove it after a gastrografin swallow performed on postoperative day 2. Since now, the choice of performing nasogastric decompression in bariatric surgery has been based upon the authors’ personal preference not depending on an evidence based approach. Only a retrospective study conducted by Huerta et al. in 2002 [48] on a series of 1067 patients operated of Roux-en-y gastric bypass documented no significant difference in terms of postoperative morbidity between two groups of patients either with or without nasogastric tube decompression: they concluded that routine placement of nasogastric tube after gastric bypass is not necessary. Also in traditional upper digestive surgery it was largely demonstrated that routine use of postoperative nasogastric tube decompression is not useful [49–52]. Differently, no study has been performed on patients operated of LSG: at our knowledge, our trial is the first one debating on the role of nasogastric decompression in this kind of operation. Our results seem to confirm the evidences issued by the study conducted by Huerta, as it can be seen in Table 2: the differences in terms of leaks’ incidence between group A and group B (1.4% vs. 0%, respectively) were not statistically significant. It is interesting to note that the only leak occurred in the group A, where the nasogastric tube was used. In our opinion, this observation is strengthened by the fact that, differently from other authors, who prefer removing it on the first postoperative day, we kept the nasogastric tube until the 5th postoperative day. Our choice was determined by routine postoperative management for patients operated of sleeve gastrectomy in our department. Usually, we perform gastrografin swallow on 5th postoperative day, as we prefer to keep a cautious approach for this kind of operations and patients. This is the reason why postoperative length of stay was significantly longer in our study, overall in group A. Another consideration can be done: usually, primary reason for performing nasogastric decompression in the first postoperative days is to avoid nausea and vomiting. In our study, no patient complained of these symptoms also in group B where no nasogastric tube was used. Finally, a last consideration: mean output of the nasogastric tube was very low (68 ± 21 ml per day). Can it really represent a mechanical stress factor on the staple suture line?
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CONCLUSIONS According to our results, routine placement of nasogastric tube in patients operated of LSG seems not useful in reducing leaks’ incidence. We suggest to avoid its routinary use also considering the undeniable discomfort for the patients. Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the article.
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The procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation and with the Helsinki Declaration of 1975, as revised in 2000.
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SURGICAL TECHNIQUES
Is Nasogastric Decompression Useful in Prevention of Leaks After Laparoscopic Sleeve Gastrectomy? A Randomized Trial
J Invest Surg Downloaded from informahealthcare.com by Yale Dermatologic Surgery on 12/29/14 For personal use only.
Gianluca Rossetti, MD,1 Landino Fei,1 Ludovico Docimo,2 Gianmattia Del Genio,2 Fausta Micanti,1 Annamaria Belfiore,1 Luigi Brusciano,2 Francesco Moccia,1 Marco Cimmino,1 Teresa Marra1 1
Digestive Surgery Unit, Second University of Naples, via Pansini 5, Naples, Italy, 2 Unit of Obesity Surgery, Second University of Naples, via Pansini 5, Naples, Italy
ABSTRACT Introduction: Although its excellent results, laparoscopic sleeve gastrectomy (LSG) presents major complications ranging from 0% to 29%. Among them, the staple line leak presents an incidence varying from 0% to 7%. Many trials debated about different solutions in order to reduce leaks’ incidence. No author has investigated the role of gastric decompression in the prevention of this complication. Aim of our work is to evaluate if this procedure can play a role in avoiding the occurrence of staple line leaks after LSG. Materials and Methods: Between January 2008 and November 2012, 145 patients were prospectively and randomly included in the study. Seventy patients composed the group A, whose operations were completed with placement of nasogastric tube; the other 75 patients were included in the group B, in which no nasogastric tube was placed. Results: No statistical differences were observed between group A and group B regarding gender distribution, age, weight, and BMI. No intraoperative complications and no conversion occurred in both groups. Intraoperative blood loss (50.1 ± 42.3 vs. 52.5 ± 37.6 ml, respectively) and operative time (65.4 ± 25.5 vs. 62.6 ± 27.8 min, respectively) were comparable between the two groups (p: NS). One staple line leak (1.4%) occurred on 6th postoperative day in group A patients. No leak was observed in group B patients. Postoperative hospital stay was significantly longer in group A vs. group B patients (7.6 ± 3.4 vs. 6.2 ± 3.1 days, respectively, p: 0.04). Conclusions: Routine placement of nasogastric tube in patients operated of LSG seems not useful in reducing leaks’ incidence. Keywords: Bariatric surgery; sleeve gastrectomy; laparoscopy; staple line leak; nasogastric tube
INTRODUCTION
trectomy (LSG) is becoming a popular restrictive procedure [5–9]. It has quickly attracted surgical interest because it does not require gastrointestinal anastomosis nor the use of a foreign material (gastric band) and it is considered less technically challenging than other bariatric interventions [10–12]. Many authors support LSG as a first step in high-risk patients and in those with a high BMI, with the aim of performing a second final procedure after an acceptable degree of weight loss to reduce surgical risk. However, now LSG is increasingly being accepted as a valid stand-alone procedure for the surgical treatment of obesity as it is effective in achieving 60%–70% excess weight loss at a follow up of almost three years [13], comparable with
Obesity represents a worldwide epidemic and has become a major medical and social problem of western countries. In 2025, 40% of US population will be obese according to current alimentary trends [1]. For patients with morbid obesity (obesity class II or III), surgical management remains the only evidence-based approach to achieve relevant long-term weight loss [2, 3]. A minimally invasive approach to the surgical management of obesity has been shown to dramatically reduce perioperative morbidity through reduced blood loss, hospital stay and wound complications [4]. Among the different surgical procedures, laparoscopic sleeve gasReceived 7 October 2013; accepted 11 December 2013.
Address correspondence to Dr Gianluca Rossetti, MD, Digestive Surgery Unit, Second University of Naples, via Pansini 5, Naples 80131, Italy. E-mail: [email protected]
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Sleeve Gastrectomy Leaks Prevention other bariatric procedures [14–17]. Despite these excellent results, LSG is not free from significant morbidity. In a recent review, the mortality rate was 0–3.3%, while major complications (bleeding, abscess, leak) ranged from 0% to 29% (average 12%) [13]. Among them, the staple line leak is the most fearful with a varying incidence from 0% to 7% [13, 18– 23]. Many trials have been published debating about the role of reinforcement of the suture staple line in order to reduce leaks’ incidence [24–28], but no definitive conclusion can be drawn on the argument. Instead, at our knowledge, no author has investigated the possible role of gastric decompression in the prevention of this complication. Aim of our work is to evaluate, in a randomized controlled trial, if this procedure can play a role in avoiding the occurrence of suture staple line leaks after LSG.
TABLE 1
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Patients characteristics
Characteristics Gender (n) Female Male Age (years) Mean ± SD Range Weight (Kg) Mean ± SD Range BMI (kg/m2 ) Mean ± SD Range BMI>50 Hypertension Diabetes Sleep apnea
Group A
Group B
P
39 (55.7%) 31 (44.3%)
40 (53.3%) 35 (46.7%)
0.22(NS)
33.8 ± 7.4 21–58
36.9 ± 8.7 19–59
0.13(NS)
132.1 ± 18.3 105–185
137.6 ± 21.2 100–190
0.11(NS)
46.4 ± 6.3 42–58.3 15 (21.4%) 22 (31.4%) 16 (22.9%) 7 (10.0%)
48.1 ± 7.1 40–57.9 18 (25.3%) 20 (26.6%) 18 (24.0%) 8 (10.7%)
0.24(NS) 0.31(NS) 0.15(NS) 0.28(NS) 0.18(NS)
MATERIALS AND METHODS Between January 2008 and November 2012, 209 patients affected with morbid obesity came to our observation. Of these, 145 were prospectively and randomly included in the study approved by the ethics committee: 70 patients composed the group A whose operations were completed with the placement of a nasogastric tube; the other 75 patients were included in the group B in which no nasogastric tube was placed at the end of the intervention. All the operations were performed by the same operative team. Inclusion criteria were a body mass index (BMI) greater than 40 kg/m2 or greater than 35 kg/m2 associated with relevant comorbidities. Exclusion criteria were the inability to undergo general anesthesia, age greater than 60 years and BMI > 60. Patients were addressed to LSG after a multidisciplinary team evaluation including a surgical, psychiatric, nutritional, and endocrinological visit. Preoperative investigations included the following: complete blood laboratory examens, electrocardiogram and cardiologic visit, chest X-ray and pulmonary function test, gastroscopy, and abdominal ultrasound. In case of grade I esophagitis and/or hiatal hernia >3 cm, the patients were addressed to Roux-en-y gastric bypass. The following co-morbidities were present in the two groups: arterial hypertension in 22 patients, type II diabetes in 16 patients, and sleep apnea in 7 patients in group A, while they were respectively observed in 20, 18, and 8 patients in group B (Table 1).
Statistical Analysis Quantitative data were expressed as mean or range. Statistical analysis was performed using the chi-square test (Pearson, Mantel–Haenzel test for linear association) with the Yate’s correction or the Fisher’s exact test and Mann–Whitney U-test whenever needed. The pvalue was considered statistically significant when be C
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low 0.05. The statistical package used was SPSS 16.0 (SPSS Inc., Chicago, IL).
Surgical Technique All the operations were conducted under general anesthesia. Induction was carried out with midazolam 0.3 mg/kg, propofol 1.5 mg/kg, and rocuronium 0.9 mg/kg intravenous (IV) for tracheal intubation. The maintenance was performed with remifentanil 0.15–0.25 μg/kg/min, isoflurane 1% mixture of oxygen and air 1:1, and additional dose of rocuronium if necessary. At the induction, a single dose of IV third generation cephalosporine was administered for a short-term antibiotic prophylaxis. The patient was placed in a lithotomic and reverse Trendelenburg position with sequential compression of lower limbs. Operating surgeon was placed between the patient’s legs. After pneumoperitoneum induction at a 15 mmHg value by a Veress needle, five trocars were introduced. The first one was positioned under direct vision with an OptiView trocar (Ethicon Endo-Surgery, Cincinnati, OH). The other four trocars, two 5 mm and two 12 mm, were introduced under direct vision. Dissection of the greater curvature started at almost 6–7 cm from the pylorus and was conducted upwards until the angle of His by means of LigasureTM (Covidien, Mansflield, MA). Attention was paid in mobilizing the entire fundus to the mid-portion of the left crura of the diaphragm. Then, a 36-Fr bougie was inserted by the anesthesiologist into the stomach and directed closely along lesser curvature toward the pylorus. Resection of the antrum started parallel to the bougie from the right lateral port using the Echelon 60 Endopath (Ethicon Endo-Surgery, Cincinnati, OH) with gold cartridge (3.8 mm). After the first two firings, the resection of the body and fundus of the stomach was
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performed using blue cartridges (3.5 mm) via the left mid-clavicular port site to the angle of His. All stapling was performed holding initial compression for a minimum of 15 s between the strokes of the device. We did not mobilize the periesophageal fat pad in order to leave approximately 1 cm of gastric tissue lateral to the angle of His. Routinely, we did not use buttress material neither over-sewed the staple line. Only in case of persistent bleeding, we positioned some interrupted stitches along the suture line. Once the gastric partition had been completed, an upper endoscopy was performed to check the integrity of the suture line: air was insufflated and irrigation was sprayed over the staple line to check for leaks. Resected stomach was extracted from the abdominal cavity through a dilated 12-mm trocar incision in a specimen bag. At the end of operation, a drain was placed alongside the staple line and, in group A patients, a nasogastric tube was inserted in the stomach. The latter was removed generally on 5th postoperative day. Postoperative analgesia was done with intravenous ketorolac 90 mg/die and tramadol 300 mg/die for the first 24 hr. All the patients received in the early postoperative period intravenous hydration and proton pump inhibitors (PPI) at a dose of 40 mg per day until the beginning of oral alimentation. Upper GI X-ray was carried out in all patients on the 5th postoperative day. They were discharged home on the 6th postoperative day with prescription of a 40 mg per day oral PPI therapy for six months. Liquid diet started on 6th postoperative day and was allowed for 10–15 days under strict nutritionist surveillance. All the patients underwent clinical follow-up at three months and six months from the operation.
RESULTS No statistical differences were observed between group A and group B patients regarding gender distribution, age, weight, and BMI as it is reported in Table 1. No intraoperative complications occurred in both groups and all the interventions were completed via laparoscopic approach. No significant differences were observed between the two groups in terms of intraoperative blood loss and operative time, as it is showed in Table 2. Mean output of nasogastric tube was 68 ± 21 ml per day. It consisted mainly of gastric juice. No nausea and vomiting were complained by the patients either in group A or in group B. The following postoperative complications occurred in three patients: two bleedings, one in group A (1.4%) and one in group B (1.3%), and one staple line leak on the 6th postoperative day in group A (1.4%) (Table 2). In all cases, conservative therapy was successful and no reoperation was necessary. The only leak occurred in group A was located 2–3 cm below the gastroesophageal junction: it was treated with total parenteral nutrition and spontaneously healed in 25 days. The differences between
TABLE 2
Perioperative results
Parameters Intraoperative blood loss (ml) Mean ± SD Range Operative time (min) Mean ± SD Range Overall morbidity Leak Hospital stay Mean ± SD Range
Group A
Group B
P value
50.1 ± 42.3 20–250
52.5 ± 37.6 30–220
0.16 (NS)
65.4 ± 25.5 50–120 2 (2.8%) 1 (1.4%)
62.6 ± 27.8 55–130 1 (1.3%) 0 (0%)
0.13 (NS)
7.6 ± 3.4 5–25
6.2 ± 3.1 5–13
0.11 (NS) 0.09 (NS) 0.04
the two groups in terms of overall morbidity and leak incidence were not statistically significant (Table 2). Postoperative hospital stay was significantly longer in group A patients (p < .04) (Table 2). At clinical followup, at three and six months from the operation, no patient, either in group A or group B, presented clinical signs of leak.
DISCUSSION Although LSG is worldwide considered as a successful surgical procedure for morbid obesity, it is not free from significant complications, among which the staple line leak is the most fearful with a varying incidence from 0% to 7% [13, 18–23]. Etiology of leaks can be classified into mechanical and ischemic causes, which include tension, ischemia, poor wound healing, technical errors, inappropriate instrument use, and iatrogenic injury. Ischemic leaks occur generally 5–7 days postoperatively, when wound healing is between the inflammatory and fibrotic phases, whereas the most common causes of leaks that occur within the first 48 hr are mechanical [29]. Aiming to reduce leaks’ incidence, relevant steps include careful tissue management, optimal use of endostaplers, prevention of distal stenosis, and good hemostasis. When using endostaplers, it is considered determining to begin tissue compression carefully and maintain this position for enough time to allow the tissue fluids to exit. Some authors advise waiting for around 10 [30] or 30–60 s [25] after stapler closure before firing: Kasalicky et al. [25] reported no leaks at 18-months follow-up with this technique. Other authors, such as Bellanger et al. [23], suggested avoiding the incorporation of the area of the gastroesophageal junction into the suture line: they observed a 0% leak rate in a series of 529 sleeve gastrectomies performed. However, most authors suggest the use of staple line reinforcement in order to prevent suture line leak. The 2009 international consensus conference on sleeve gastrectomy reported that staple line reinforcement was performed by 65.1% of Journal of Investigative Surgery
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Sleeve Gastrectomy Leaks Prevention the surgeons’ responders: 42.1% used buttressing materials, 50.9% oversewed the staple line, and 7.0% used both methods [6]. Different materials have been used: Seamguard (Gore, Falstaff, AZ, USA), an absorbable polymer membrane constituted of polyglycolic acid (67%) and trimethylene carbonate (33%), is one of the R , most frequently employed. Fibrin sealants (Tissucol R R (PSD, Synovis), Vivostat ) and Peri-Strips Dry segments of dehydrated bovine pericardium, are also used: some studies have reported a decreased leak incidence with these materials [31–34]. Other authors prefer protecting the staple line with a continuous sero-serous suture: in their opinion, this technique is able to reduce the number of leaks as it inverts the staples and controls bleeding [35–37]. However, a recent trial documented no significant difference in terms of postoperative morbidity rates between buttressing staple line with Seamguard and staple line suturing [38]. Moreover, another prospective randomized trial demonstrated that even not performing a staple line reinforcement, results in terms of leak incidence were comparable with the two previous techniques [27]. These results have been confirmed also in a recent review [39]. We agree with the conclusion of these studies as, in our experience, we routinely do not perform any staple line protection: only in case of persistent bleeding, we position some interrupted stitches along the suture line. Our results support this choice: in fact, leak incidence in our series (1/145, 0.6%) is overall comparable with the experiences reported in the literature [13, 18–23]. We consider determining a careful tissue manipulation, an accurate hemostasis and primarily keeping the stapler at a distance of almost 2–3 cm from the angle of His in order to preserve blood supply of the esophagogastric junction; moreover, we always keep in mind to maintain stapler closure for almost 15–20 s before firing, as recommended. Another determining factor for leak occurrence, especially below the gastroesophageal junction, could be depending on the development of high intra-luminal pressure consequential to the long vertical tubulization of the stomach [40, 41]. Yehoshua [41] observed an increased intragastric pressure in the sleeved stomach (mean 43 ± 8 mmHg), whereas mean intragastric pressure in a normal stomach is 34 ± 6 mmHg. This pressure is amplified by the fact that the compliance of the sleeve is ten times less than the complete stomach or the resected fundus [40, 41]. This physical situation could be a determining factor for leaks occurrence, because the thickness of the gastric tissue varies between the antrum, the body, and the fundus (3.1 mm, 2.4 mm, and 1.7 mm, respectively) [42]. For this reason, the gastric tissue at the angle of His could be more prone to leak occurrence. According to this observation, Gagner documented an inverse relationship between bougie size and leak rate and advocates using a bougie size between 50 and 60 French to minimize this complication C
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[43]. This evidence has been confirmed also in a recent review [44]. Since the reduction of intragastric pressure could help in reducing leaks’ incidence, a matter of debate can be represented by the role of nasogastric decompression in the first postoperative days aiming to reduce the mechanical stress on the staple suture line. Most authors, mainly from USA, routinely do not perform nasogastric decompression as they discharge patients on postoperative day 1. Only few surgical teams specifically mention that they place nasogastric tube during the first two postoperative days [20, 26, 37, 45–47]. Usually, they remove it after a gastrografin swallow performed on postoperative day 2. Since now, the choice of performing nasogastric decompression in bariatric surgery has been based upon the authors’ personal preference not depending on an evidence based approach. Only a retrospective study conducted by Huerta et al. in 2002 [48] on a series of 1067 patients operated of Roux-en-y gastric bypass documented no significant difference in terms of postoperative morbidity between two groups of patients either with or without nasogastric tube decompression: they concluded that routine placement of nasogastric tube after gastric bypass is not necessary. Also in traditional upper digestive surgery it was largely demonstrated that routine use of postoperative nasogastric tube decompression is not useful [49–52]. Differently, no study has been performed on patients operated of LSG: at our knowledge, our trial is the first one debating on the role of nasogastric decompression in this kind of operation. Our results seem to confirm the evidences issued by the study conducted by Huerta, as it can be seen in Table 2: the differences in terms of leaks’ incidence between group A and group B (1.4% vs. 0%, respectively) were not statistically significant. It is interesting to note that the only leak occurred in the group A, where the nasogastric tube was used. In our opinion, this observation is strengthened by the fact that, differently from other authors, who prefer removing it on the first postoperative day, we kept the nasogastric tube until the 5th postoperative day. Our choice was determined by routine postoperative management for patients operated of sleeve gastrectomy in our department. Usually, we perform gastrografin swallow on 5th postoperative day, as we prefer to keep a cautious approach for this kind of operations and patients. This is the reason why postoperative length of stay was significantly longer in our study, overall in group A. Another consideration can be done: usually, primary reason for performing nasogastric decompression in the first postoperative days is to avoid nausea and vomiting. In our study, no patient complained of these symptoms also in group B where no nasogastric tube was used. Finally, a last consideration: mean output of the nasogastric tube was very low (68 ± 21 ml per day). Can it really represent a mechanical stress factor on the staple suture line?
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CONCLUSIONS According to our results, routine placement of nasogastric tube in patients operated of LSG seems not useful in reducing leaks’ incidence. We suggest to avoid its routinary use also considering the undeniable discomfort for the patients. Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the article.
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The procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation and with the Helsinki Declaration of 1975, as revised in 2000.
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