Reinforced Sleeve versus Non-Reinforced Sleeve Gastrectomy in Morbid Obese Patients: A comparative Study

Reinforced Sleeve versus Non-Reinforced Sleeve Gastrectomy in Morbid Obese Patients: A comparative Study

Mohamed G. Fouly, MD; Ahmed Y. Elrifaie, MD; Ahmed M. Farrag, MD

Department of Surgery, Faculty of Medicine, Ain Shams University, Egypt

Background: Staple-line leaks after laparoscopic sleeve gastrectomy (LSG) remains a concerning complication in addition to other complications which may occur as bleeding and twisting. Buttressing of the staple line after sleeve gastrectomy is an acceptable reinforcement method but data recorded regarding leaks have been equivocal. Intraoperative measures are used as over-sewing of stapling line to prevent these events and several other methods are used to decrease and control these complications and decrease these burden. Although staple-line reinforcement in several studies is reported to decrease postoperative leakage and bleeding, other studies reported that reinforcement has no role. Authors also reported using buttressing materials. Our study is to compare between sleeve gastrectomy vs. reinforced sleeve gastrectomy with over-sewing of the staple line and omentopexy in morbid obese patients as regards overall complications as bleeding, Leakage and twist.

Patients and methods: This prospective randomized Controlled trial involved 500 obese patients conducted during period from January 2018 to January 2019 with follow up till June 2019. The patients were divided into 2 groups, Group A (250 patients) underwent sleeve gastrectomy then reinforcement by suturing of sleeved stomach along the whole length of staple line with omentopexy and Group B (250 patients) underwent sleeve gastrectomy with no over sewing or omental patching.

Results: There was a significant difference between the two study groups as regard operative time with longer mean operative time in omentopexy group. However, no statistically significant difference was found between the two study groups as regard post-operative leakage, hemorrhage and twisting although overall complications  was less in reinforcement group and leaks detected in reinforcement group are mostly contained leaks but this was statistically insignificant.

Conclusion: Minimal advantage is added to sleeve gastrectomy with reinforcement by over-sewing and omentopexy as regard post-operative leakage, hemorrhage and twisting although overall complications was less in reinforcement group and leaks detected in reinforcement group are mostly contained leaks but this was statistically insignificant so further studies is needed with larger sample size.

Key words: Reinforced sleeve, twist, leakage, bleeding, omentopexy.

Introduction

Obesity is a burden on individuals and society. Obesity has rates of death driven by co-morbidities such as hypertension, diabetes, sleep apnea, steato- hepatitis, gastro-esophageal reflux disease (GERD), arthritis, polycystic ovary disease and infertility.1-4 

Sleeve gastrectomy (LSG) was presented as a part of the duodenal switch with bilio-pancreatic diversion. Now, it is universally known primary procedure.5,6 

LSG is efficient, safe and simple procedure for morbid obesity with improvement in comorbidities and satisfactory results in follow up results.7-9

Recent  studies  demonstrated  that  LSG  is  not only a restrictive procedure, as gut hormones interactions e.g.  (Ghrelin, PYY, and incretins) were demonstrated. So, hormonal interactions were adding power to action of Sleeve gastrectomy increasing its efficacy and maintenance in loss of weight in follow up data.10-12 

Leak due to staple-line disruption, bleeding, strictures and twist are reported complications with varying severity and varying methods of management from conservative measures to more interventions, e.g., blood transfusion in bleeding, second-look in more complicated cases, and further interventions as considering conversion to bypass in some cases of leak. Leak is the most serious complication and its incidence is reported to be up to 2–5%.10,13 Bleeding  after  LSG  incidence  is  reported  to  be 1–6%. Either intraluminal or abdominal bleeding was reported; intra-abdominal bleeding source could be the staple line which in most cases can be conservatively managed. However, second-look laparoscopy for patients with persistent tachycardia (>120 \ minute) could be an important option for management. Also second look is indicated when there is continuous drop in hemoglobin level.13-15 

Intraoperative measures are used as over-sewing of stapling line to prevent these events and several other methods are used to decrease and control these complications and decrease these burden. Staple-line reinforcement is reported to decrease postoperative   leakage   and   bleeding.   Authors also reported using buttressing materials such as glycolide-trimethylene carbonate co-polymer to decrease these complications.16-19

Aim/ Objectives 

The aim of our study is to compare between Sleeve gastrectomy and Reinforced sleeve gastrectomy with over-sewing of the staple line and omentopexy in morbid obese patients regarding overall complications as bleeding, Leakage and twisting. 

Patients and Methods 

This prospective randomized Controlled trial involved 500 obese patients conducted at Ain Shams University Hospitals, El–Hurria Hospital, El-Thuria Hospital during period from January 2018 to January 2019 with follow up till June 2019. The patients were divided into 2 groups, Group A (250 patients) underwent sleeve gastrectomy then reinforcement by suturing of sleeved stomach along the whole length  of  staple  line  with  omentopexy  by  PDS 2/0 guided by bougie and Group B (250 patients) underwent     Sleeve  gastrectomy  with  no  over sewing or omental patching. Ethical approval was taken from Ain Shams University ethical committee and written consent was taken from every patient after explanation of all details of the operation, advantages, disadvantages, realistic expectations and all the possible intra-operative, early and late post-operative complications. Surgeries were done by the same surgical team throughout the study. 

Inclusion criteria: 

We included obese male or female patients aging from 18 to 60 years with BMI more than 35 or more than 30 with comorbidities. 

Exclusion criteria: 

We excluded from the study patients with previous bariatric surgeries, when laparoscopic sleeve is converted to open sleeve, pregnant or lactating women and patients with psychiatric disorders. 

Technique: 

We standardize the procedure in each group. Operative technique of Laparoscopic sleeve gastrectomy: The patient was positioned in French position.  Pneumoperitoneum  was  established  at 11 or 14mmHg using Visiport. Other ports were placed under direct visualization as required to establish feasible and comfortable ergonomics. (Figures 1,2).

Fig 1: Preparation, draping and positioning after anesthesia.

Fig 2: Pneumoperitoneium and ports inserted with a liver retractor.

The stomach was vertically sleeved, guided by 36 Fr bougae. Selecting appropriate staple height to accommodate  tissue  thickness,  slowly  stapling to ensure that there was no bleeding; avoiding narrowing near the angularis incisura was ensured. (Figures 3,4).

Fig  3:  Sleeved  stomach  without  omentopexy before and during methylene blue test.

Fig 4: Sleeved stomach after stapling before omentopexy.

In group A suturing of sleeved stomach along the whole length of staple line by PDS 2/0 guided by bougie  using  an  intra-corporeal  technique  with small bite technique each stitch half cm apart just beneath the staple line guided by the bougae to avoid stricture was done (Figures 5,6).

Fig 5: Steps of over-sewing and omentopexy after sleeve gastrectomy.

Fig 6: Sleeved stomach after stapling after suture reinforcement with omentopexy.

Follow up of cases: 

Follow up period was at least 6 months. Ultrasound and CBC (to exclude bleeding and leakage) were done and repeated if needed. Upper GI endoscopy was done for persistent vomiting to exclude twisting or stricture and regular follow up visits were planed after discharge for early detection of any complica- tions.

Results

When we compare both groups as regards agethere was no significant difference between the two study groups (Table 1) (Figure 7).

Table 1: Description and comparison between the two study groups as regard age

Group

Without Omentopexy                              With Omentopexy

Mean                   ±SD                         Mean                         ±SD

P             Sig

Age               35.79                   12.59                        35.58                         11.81                 0.849          NS

*Student t test.

Fig 7: Chart showing the comparison between the two study groups as regard age.

There was a statistically significant difference be- tween the two study groups as regard Operative time with longer mean operative time in omentopexy group (77.1 min vs. 48.2 min). However, no statis- tically significant difference was found between the two study groups as regard post-operative leakage, hemorrhage and twisting although complicated cas- es were less in  reinforcement groups  and leaks detected after reinforcement are mostly contained leaks (Tables 2,3) & (Figure 8).

Table 2: Description and comparison between the two study groups as regard operative and post-operative

data (operative time, leakage)

Group

Without Omentopexy                        With Omentopexy

Mean        ±SD       Min       Max      Mean     ±SD       Min      Max

P          Sig

Operative time                     48.28      21.77       19         90        77.1      12.15       40       95      0.001*       HS

Leakage

Leakage type(n=9)

* Student t test.

No                244       97.6%                                247      98.8% Yes                  6         2.4%                                   3        1.2% Contained  2         33.3%                                  2       66.7% Free                4         66.7%                                  1       33.3%

0.50**       NS

0.52**       NS

** Fisher’s Exact Test.

Table 3: Description and comparison between the two study groups as regard operative and post-operative

data (bleeding, twist)

Group

Without Omentopexy               With Omentopexy

Mean            ±SD                Mean                 ±SD

P              Sig

Hemorrhage

1.0**       NS

Twisting

1.0**       NS

*Student t test.

**Fisher’s Exact Test.

Fig 8: Chart showing the comparison between the two study groups as regard operative time.

Discussion

By revision of the literature we found leak rate vary between 1 and 3%, and overall mortality correlated to leak is about 9%.20-22    Our study is conducted on 500 patients showed that there was no significant difference between the two study groups as regard age. So, age could not be a confounder in our study between both groups. Our comparative prospective study found that omentopexy is a safe efficient technique, with satisfactory results on bleeding, leaks and twist. 

Overall complications were less in reinforcement group. There was a statistically highly significant difference between the two study groups as regard Operative time with longer mean operative time in reinforcement group (77.1 min vs. 48.2 min). A recent randomized  study  which  compares  invagination of stable line after suturing to no reinforcement demonstrated that leak rates is reduced for the suturing  with  invagination  group,  although  this costs a higher operative time by average of 18 min.23 Increased cost and operative time with intra- corporeal suturing is also demonstrated in other studies that reported an extra 13 to 24 min per case.24,25 

However, in no reinforcement group (250 patients); leaks occurred in 6 patients (2.4%) 2 of them are contained, bleeding occurred in two cases and twisting in two cases. In reinforcement group (250 patients); leaks occurred in 3 patients (1.2%) 2 of them are contained, one case had bleeding and other one had twist. Thus, no statistically significant difference was found between the two study groups as regard post-operative leakage, hemorrhage and twist. 

Twisting  may  be  presented  early  by  salivation and repeated episodes of vomiting. Late may be presented with repeated vomiting of food which may be undigested and reflux which could be refractory to medications.26  Twisting of the sleeved stomach may be due to improper alignment of stapling during firing which may be caused by unequal traction on the greater curvature of the stomach which may lead to twist of gastric tube either posteriorly or anteriorly.27 

Upper GI endoscopy is an effective tool in diagnosis of a twist.28  Although difference in twist detected in both groups was statistically insignificant, less twist in reinforcement group was noticed in our study with only one case in reinforcement group presented with persistent vomiting and twist was diagnosed with upper gastrointestinal endoscopy and the patient improved conservatively in contrast to two cases of twist in no reinforcement group detected with upper endoscopy after persistent vomiting presentation one of them conservatively improved and the other was converted to one anastomosis gastric bypass. 

It is also supported with a study that found that reattachment of the omentum with sutures to the gastric tube after stapling is effective to prevent gastric twisting.29 

Although overall complications    was less in reinforcement group and leaks detected in reinforcement group are mostly contained leaks but this was statistically insignificant so further studies is needed with larger sample size. 

This is supported with a large randomized prospective trial that showed that there was no significant difference between reinforcement and without reinforcement after sleeve gastrectomy, in terms of leakage rate.19 

Authors  also  demonstrated  that  bleeding  rate was decreased in reinforcement group and confirmed that buttressing after laparoscopic sleeve gastrectomy did not determine statistical significant evidence on leaks.30

Conclusion

Minimal advantage is added to sleeve gastrectomy with reinforcement by over-sewing and omentopexy as  regard  post-operative  leakage,  hemorrhage and twisting although overall complications   was less in reinforcement group and leaks detected in reinforcement group are mostly contained leaks but this was statistically insignificant so further studies is needed with larger sample size.

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