Surg Endosc DOI 10.1007/s00464-014-3540-8

and Other Interventional Techniques

Laparoscopic right hemicolectomy: a comparison of natural orifice versus transabdominal specimen extraction Ziad T. Awad • Reginald Griffin

Received: 25 September 2013 / Accepted: 10 March 2014 Ó Springer Science+Business Media New York 2014

Abstract Background Conventional laparoscopic right hemicolectomy (LRH) involves making an abdominal incision to remove the specimen and perform the anastomosis. Totally laparoscopic right hemicolectomy with natural orifice specimen extraction (NOSE) may lead to better outcomes compared to LRH. Study design Forty consecutive female patients total were reviewed: 20 LRH and 20 NOSE. The two groups were matched for sex, age, race, American Society of Anesthesiologist score, benign and malignant disease, tumor stage, lymph node number, tumor size, specimen length, body mass index, previous abdominal surgeries, and comorbidities. Results The two groups were comparable for all categories. Follow-up was available on all patients (100 %). The mean follow-up was 38.93 months (range 15–63 months). There was no difference between postoperative pain score between the two groups on postoperative day (POD) 1, POD 2, and POD day 14 (p = 0.571), (p = 0.861), (p = 0.688), respectively. There was no difference in the postoperative in-hospital morphine equivalents (p = 0.963). The NOSE group had no postoperative hernia formation or wound infections compared to the LRH, however, the difference was not significant (p = 0.439) and (p = 0.267), respectively. There was no difference in postoperative ileus (p = 0.192), septic complications (p = 1.000), readmission rate (p = 0.394), time interval

Z. T. Awad  R. Griffin (&) Department of Surgery, University of Florida College of Medicine Jacksonville, 633 W 8th Street, Jacksonville, FL 32209, USA e-mail: [email protected] Z. T. Awad e-mail: [email protected]

for postoperative chemotherapy (p = 0.645), SDS (p = 0.446) or QLI (p = 0.175). There was no difference in length of hospital stay with 5.3 days for the LRH group and 7.7 days for the NOSE group (p = 0.183). The NOSE group had statistically significant better cosmetic scores (p = 0.018). Conclusion NOSE is comparable LRH with regard to postoperative outcomes and quality of life. NOSE is safe and maintains strict oncologic standards. NOSE is associated with a better cosmetic outcome compared to LRH. Keywords Colorectal  Cancer  Surgical  Natural orifice specimen extraction

Since it was first reported in 1991 [1, 2], laparoscopic colectomy (LC) has been widely used for various benign and malignant colorectal diseases [3–11]. A number of single and multicenter randomized trials and meta-analysis have shown that LC has comparable oncologic outcomes to open surgery [12–18]. LC has been shown in many studies to have superior outcomes compared to their open variants, with earlier return of bowel function, decreased postoperative pain, shorter length of stay, and decreased morbidity [12, 13, 19–24]. In LC, an abdominal incision is required for specimen extraction, and occasionally to perform extracorporeal bowel anastomosis. Surgical wound complications, mainly infection and postoperative hernia formation continue to be a major problem after both open and laparoscopic colon surgery [25, 26], and the mini-laparotomy is often the most important source of postoperative pain after LC. Avoidance of the abdominal wall extraction site is desirable to maximize the benefits of LC and minimize the high cost of wound-related complications [27]. Due to the limitations of available natural orifice

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transluminal endoscopic surgery (NOTES) operating platforms, it has been a likely progression for minimally invasive surgeons to add natural orifice access to their armamentarium of innovative laparoscopic techniques. Natural orifice specimen extraction (NOSE), whereby extracting specimens from within the peritoneal cavity either through the vagina or anus have been used with increased frequency in colon surgery [28–32]. These procedures aim to reduce abdominal wall trauma in a similar fashion to pure NOTES, but offer the currently available and well-established advantages of laparoscopic instruments and techniques. The aim of the study is to compare the outcomes of patients who underwent laparoscopic right hemicolectomy (LRH) to those who underwent laparoscopic right hemicolectomy with transvaginal removal of the colon (NOSE).

Methods From July 2007–December 2011, 51 consecutive female patients underwent laparoscopic right hemicolectomy by a single surgeon (ZTA) at an academic institute. Since December 2008, we offered the NOSE approach for females undergoing laparoscopic right hemicolectomy. The study included 30 LRH and 21 NOSE. The study was done with Institutional Review Board (IRB) approval. No exclusion for the laparoscopic approach was made based on age, weight, body mass index (BMI), comorbidities, prior abdominal or pelvic surgery, pathology or indication for colectomy. Women with history of endometriosis, patient refusal, narrow vagina, extensive pelvic adhesions, inability to access the cul de sac, and lesions larger than 6 cm were not considered candidates for the transvaginal removal route. All patients in the NOSE group underwent preoperative gynecological examination to rule out vaginal stenosis, congenital abnormalities, or growths that would preclude transvaginal removal. Informed consent was obtained for all patients. We examined patient characteristic variables included age, race, height, weight, BMI, American Society of Anesthesia (ASA) score, history of previous surgery, benign and malignant disease, tumor stage, lymph node number, tumor size, length of specimen, length of hospital stay, readmission rate, and time interval to chemotherapy. We examined all pre-existing comorbid conditions including hypertension (HTN), chronic obstructive pulmonary disease, diabetes mellitus (DM), chronic kidney disease (CKD), coronary artery disease (CAD), and smoking. Postoperative pain was scored from 1 to 10, with 10 being the most severe pain. The patient’s pain was assessed every 4 h and ascribed by the nurse in the patients chart. We obtained pain scores on postoperative day POD 1, POD 2,

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and at POD 14. Postoperative narcotic use was analyzed by converting all in-hospital narcotics to intravenous morphine equivalents. We then compared the mean in-house postoperative morphine equivalents between the two groups. We analyzed early and late postoperative complications including wound infection, septic complications (anastomotic leak, intra-abdominal abscess), postoperative ileus, and hernia formation. Patient symptoms were measured using the SDS (symptoms distress score) [33]. These 13 symptoms include: nausea (frequency), nausea (intensity), appetite, insomnia, pain (frequency), pain (intensity), fatigue, bowel patterns, concentration, appearance, breathing, outlook, and cough. Responses are answered on a 5-point Likert Scale ranging from 1 (no distress) to 5 (extreme distress). The 13 items can be summed to provide total symptom distress ranging from 13 to 65. Higher scores denote greater levels of symptom distress. The quality of life was measured using the quality of life index QLI [34]. The QLI measures 5 domains (activity, daily living, health, support, and outlook). Each item has response categories describing normal functioning (scored as 0), moderately impaired functioning (scored as 1), and severely impaired functioning (scored as 2). The QLI summary score is a total of these items, with higher scores indicating poorer QOL. The cosmetic score was scaled from 1 to 10, with 10 being the most appealing result. SDS, QLI, and cosmetic scores were conducted by telephone interview by an independent physician who was blinded to the two groups. Differences between groups were calculated using Chi square and Fisher’s exact test for categorical variables. Student’s t test was used for continuous data with 95 % confidence intervals. Mann–Whitney U test and Kruskall–Wallis test were used for nonparametric statistics. Our technique of laparoscopic right hemicolectomy with intracorporeal anastomosis and transvaginal removal of the colon has been recently described [30]. LRH was performed in a similar manner except the specimen was removed through a wound protection system (Applied Medical, Rancho Santa Margarita, CA, USA) within a 4-cm periumbilical incision.

Results Since December 2008 we adopted the NOSE approach; nine patients opted for the conventional LRH, and in one patient the transvaginal extraction part was aborted intraoperatively as the lesion was large (8.0 cm). There was no 30 day mortality and no conversion to open surgery in either group. Ten patients in the LRH were excluded from final analysis due to death (liver metastasis, n = 2;

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myocardial infarction, n = 2; primary lung cancer, n = 1; lung and liver metastasis, n = 1; heart failure, n = 1; failure to thrive and dementia, n = 1; and enterococcal sepsis, n = 1; urosepsis, n = 1). In all, death was unrelated to the surgical procedure. One patient in the NOSE group was lost to follow-up with 20 LRH and 20 NOSE patients remaining. The mean follow-up in the LRH group was 52.65 months (range 30–66) compared to 31.2 months (range 15–51) in the NOSE group (p = 0.00001). The two groups were statistically homogeneous when compared for age (p = 0.980), ASA (p = 0.210), pathology (p = 0.350), tumor stage (p = 0.420), lymph node number (p = 0.370), BMI (p = 0.390), race (p = 0.180), previous abdominal surgery (p = 0.690), or comorbidities: COPD (p = 0.900), CAD (p = 0.900), HTN (p = 0.900), DM (p = 0.160), smoking (p = 0.360), and CKD (p = 0.900) (Table 1). There was no difference between the two groups for length of stay with LRH group incurring a mean of 5.3 days (range 2–12) compared to a mean of 7.7 days (range 2–23) in the NOSE group with (p = 0.183). The readmission rate (p = 0.394), or time interval for postoperative chemotherapy (p = 0.645) did not show any significant difference between the two groups (Table 1). There was no difference in the size of the lesion (p = 0.445) and length of specimen (p = 0.142) removed between the two groups. There was no difference between postoperative in-hospital narcotic equivalents used between the two groups (p = 0.963). No difference was found in postoperative pain score at POD 1 (p = 0.571), POD 2 (p = 0.861) or at POD 14 (p = 0.688) (Fig. 1). Postoperative complications are shown in (Fig. 2). There were two postoperative incisional hernia in the LRH and none in the NOSE group (p = 0.439). There was one surgical site infection in the LRH, and none in the NOSE group (p = 0.267). There were no septic complications (anastomotic leak, intraabdominal abscess) identified in either group. Postoperative ileus developed in seven and two patients in the LRH and NOSE group, respectively (p = 0.192). The NOSE group had a mean cosmetic score of 9.7 compared with a mean score of 8 in the LRH group with scale of 1–10 with 10 being the most appealing result (p = 0.018) (Fig. 3). SDS and QLI showed no statistical differences between the NOSE and LRH groups (SDS mean scores of 17.7 vs. 15) (p = 0.446), and (QLI mean scores 1.6 vs. 0.6) (p = 0.175) (Fig. 4). Finally, comparison of the operative time showed that the NOSE procedures takes significantly longer time compared to the LRH, mean operative time of 3.71 h (range 2.27–5.05) versus 2.47 h (range 1.25–4.3) in the LRH group (p = 0.0002).

Table 1 Comparison of laparoscopic right hemicolectomy (LRH) to the natural orifice specimen extraction (NOSE) group Variable

LRH Mean (std)

NOSE Mean (std)

p value

Age

63.6 (9.08)

66.9 (8.9)

0.980

Height (cm)

162.9 (9.52)

163.7 (8.61)

0.710

BMI

31.6 (8.33)

25.1 (6.65)

0.390

Weight (kg)

85.0 (23.58)

66.9 (15.34)

0.100

Lymph node number

20.8 (8.73)

17.8 (5.23)

0.370

Size of the lesion (cm)

3.42 (1.16)

4.735 (3.61)

0.445

Length of specimen (cm)

40.075 (26.77)

24.390 (5.889)

0.142

Time interval to chemo (weeks)

5.9 (1.21)

6.0 (0.00)

0.645

Length of hospital stay (days)

5.3 (2.81)

7.70 (5.17)

0.183

Postoperative in-hospital IV morphine equivalents (mg)

128.69 (96.69)

130.53 (102.69)

0.963

Frequency (%)

Frequency (%)

Race 1 = African American

7 (17.5 %)

9 (22.5 %)

2 = Caucasian

11 (27.5 %)

11 (27.5 %)

3 = Hispanic

2 (5 %)

0

0.180

ASA 1

1 (2.5 %)

0

2

4 (10 %)

4 (10 %)

3

15 (37.5 %)

15 (37.5 %)

4

0

1 (2.5 %)

0.210

Previous surgery

18 (45 %)

14 (35 %)

0.690

COPD

2 (5 %)

1 (2.5 %)

0.900

Hypertension

13 (32.5 %)

14 (35 %)

0.900

Diabetes

6 (15 %)

5 (12.5 %)

0.160

Chronic kidney disease

2 (5 %)

4 (10 %)

0.900

Coronary artery disease

4 (10 %)

2 (5 %)

0.900

Smoking

5 (12.5 %)

12 (30 %)

0.360

Benign

9 (45 %)

6 (30 %)

0.350

Malignant

11 (55 %)

14 (70 %)

I

2 (5 %)

8 (20 %)

II

5 (12.5 %)

2 (5 %)

III

4 (10 %)

4 (10 %)

3 (7.5 %)

2 (5 %)

Pathology

Stage

Readmission rate

0.420

0.394

One patient in the NOSE group developed postoperative dyspareunia that resolved 1 year after surgery. One patient in the NOSE group developed postoperative vaginal discharge 1 week after surgery; it was minimal, and resolved in 6 months. Another patient is 50-year-old female with HIV, dialysis dependent with T3 N1 M0 colon cancer, developed bloody vaginal discharge 1 month after surgery

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NOSE

p = 0.446 17.7 15

p = 0.175

1.3

Fig. 1 Postoperative pain comparison between NOSE and LRH

SDS (13-65)

0.6

QLI (0-10)

Fig. 4 Comparison of quality of life between NOSE group and LRH group

Discussion

Fig. 2 Postoperative complications between NOSE group and LRH group

Fig. 3 Comparison of cosmetic result between NOSE group and LRH group

and is still present at 19 months follow-up. Gynecological assessment confirmed the bleeding as post-menopausal related to atrophic vagina and endometrium. Tranvaginal ultrasound showed a thin endometrium and normal cervix; no abnormality is seen.

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The use of natural access points to minimize the need for larger incisions is a logical progression in minimally invasive surgery. Elimination of large abdominal wall incisions using the NOSE approach may help to further reduce postoperative morbidity. Our study showed no difference between the NOSE and LRH groups in postoperative pain score, postoperative narcotic use, length of hospital stay, postoperative complications, readmission rates, SDS, and QLI. In the NOSE group, there were no wound infection or and incisional hernia in all 20 patients. In the LRH group, there were two patients with incisional hernias and one patient with wound infection. Despite these observational differences, there was no statistical difference between our two groups with regard to wound morbidities. This is most likely attributable to the small number of study population. Other studies also showed no woundrelated complications in the NOSE group [35, 36]. Our study showed that NOSE is associated with significantly better cosmetic score. The main limitations of our study include: retrospective and non-randomized; also, the small patients groups and relatively short term follow- up. The NOSE procedures takes significantly longer time compared to the LRH; the mean operative time 3.71 versus 2.47 h (p = 0.0002). However, we noticed a steady decrease in the operative time for the NOSE approach which is related to the learning curve, and different level residents’ familiarity with the technical aspects of the new approach. The mean length of hospital stay in our study is of 7.7 and 5.3 days for the NOSE and LRH groups, respectively, is comparable to the reported length of hospital stay after laparoscopic colectomy in randomized controlled trials [12, 13, 37–39]. It is only recently that we

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adopted the enhanced recovery pathway at our institution for patients undergoing laparoscopic colorectal surgery as we believe it will shorten length of hospital stay. In one of our patients, the lesion was too large for safe tranvaginal removal. We believe that it is not only the size of the lesion but also the thickness of the mesentery and stretch capacity of the vagina that determines the feasibility of the transvaginal approach. Wilson et al. [40] performed laparoscopic right hemicolectomy with tranvaginal removal for 5 9 8 cm hepatic flexure cancer. Lakshman et al. [41] reported two cases of advanced colorectal cancer, one with ovarian invasion and one with uterine invasion, which were managed using the transvaginal approach. Other studies proposed a 5 or 7 cm limit for safe transvaginal extraction [35, 42]. Colpotomy-related complications in our series (dyspareunia, 1; vaginal discharge, 1) were comparable to reported complications form large gynecology series [43, 44]. There have been no randomized control trials to date comparing NOSE to LRH. However, the validity of the NOSE approach has been consistently demonstrated by multiple reports from institutions around the world. Our own initial experience at this institution found that the NOSE approach is safe and effective with low postoperative complication rates [30]. Park et al. [29] reported on 14 patients with right side/hepatic flexure colon-transverse colon cancer who underwent totally laparoscopic right hemicolectomy with transvaginal removal of the colon. They used the vaginal access site for port placement through which the anastomosis was performed. In two patients, transvaginal specimen removal was not possible because of inadequate posterior colpotomy. There were no intraoperative, wounds, or complications related to the transvaginal removal site. The same group published the largest series in the literature comparing the clinical outcomes of totally laparoscopic right hemicolectomy with NOSE (n = 34) with conventional laparoscopic-assisted right hemicolectomy (n = 34) [35]. The NOSE group experienced less postoperative pain on postoperative day 1 and 3 (p = 0.001, p = 0.010) and had a shorter hospital stay [mean (s.d.) 7.9(0.8) vs. 8.8 (1.5) days; p = 0.003]. At mean follow-up of 23 months, there was no transvaginal access site recurrence or posterior colpotomy-related complications. NOSE was associated with significantly better cosmetic results. Of note, no quality of life validated tools was used.

Conclusions In conclusion, the NOSE approach is comparable to conventional LRH in postoperative outcomes and quality of life indices. NOSE is associated with a better cosmetic

outcome compared to LRH. Prospective randomized trial with larger patient population and longer follow-up is needed.

Disclosures Ziad T. Awad and Reginald Griffin have no conflict of interest or financial ties to disclose.

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Laparoscopic right hemicolectomy: a comparison of natural orifice versus transabdominal specimen extraction.

Conventional laparoscopic right hemicolectomy (LRH) involves making an abdominal incision to remove the specimen and perform the anastomosis. Totally ...
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