Comparison of Stapled and Hand-Sewn Sleeve Gastrectomy

NCT ID: NCT03982823

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-01
• Study Completion Date: 2014-12-31

Brief Summary

Sleeve gastrectomy is a stapler dependent bariatric procedure. A hand-sewn sleeve gastrectomy can be necessary under certain circumstances. Here, the investigatorsaimed to compare the outcomes of hand-sewn and stapled sleeve gastrectomies for the first time.

In the hand-sewn group, no staplers were used and after vertical resection of the stomach by energy devices, the remnant stomach was closed by two rows intracorporeal sutures. In the stapler group, sleeve gastrectomy was done in the usual way.

Detailed Description

Nowadays, morbid obesity is a major health problem that the investigatorsface in every age groups. In the treatment of morbid obesity, sleeve gastrectomy is applied more and more frequently. However, sleeve gastrectomy is a stapler dependent operation and sleeve gastrectomy without the use of staplers was very limited in the literature [1]. Hand-sewn sleeve gastrectomy can rarely be necessary in some special conditions such as technical defects of the staplers, patients allergies to titanium clips or sometimes when staplers were unusable [1]. As far as the investigatorsknow, there was no study that compare the results of stapled and hand-sewn sleeve gastrectomies so far. The purpose of this study was to compare the hand-sewn and stapled sleeve gastrectomies in a small case series.

In June 2013, the investigatorslaunched a natural orifice surgery program including several procedures. In this context, the investigatorsplanned natural orifice (transoral) extraction of sleeve gastrectomy specimens. Patients who were eligible and agree with participation to the hand-sewn sleeve gastectomy combine with transoral specimen extraction study were accepted to two group. This study is conducted according to the STROCSS criteria. Total six morbidly obese patients (body mass index more than 40 kg/m2) who had undergone hand-sewn sleeve gastrectomy between the dates May-2014 and December 2014, were investigated retrospectively. In the same time period, seven another morbidly obese patients included in the control group were treated with stapled sleeve gastrectomies. Grouping was done by the acceptance of the patients. The hand-sewn sleeve gastrectomy group combined with natural orifice surgery. Patients who do not participate the hand-sewn group were treated by the stapled sleeve gastrectomy and the specimens were extracted through the trocar site. In both groups, patients' age, gender, height, weight, body mass index, comorbidity, and lifestyle properties were recorded. Intraoperative blood loss, operating time, length of hospital stay, postoperative complications, and the metabolic/bariatric results of the two groups in one and three years were evaluated. Statistical comparisons were performed with nonparametric statistical tests (Mann-Whitney U-test and Wilcoxon Signed Rank Test to analyze numerical data, and Fisher exact test to analyze cathegorical data). Numerical data expressed as median and range. P<0.05 was considered as significant.

In the hand-sewn group, following pneumoperitoneum with a Veres needle, the first 5 mm trocar was entered 14 cm down and 4 cm left from the xyphoid process. Other two 5 mm trocars were applied to the left and right upper quadrant. Last two 5 mm trocars were placed just below the xyphoid process for automatic liver retractor and through the epigastrium as a working port. A 5 mm 300 optic camera was used and the intraabdominal pressure was set to 14 mmHg. Gastrocolic and gastrosplenic ligaments were divided by 5 mm Ligasure (Force Triad, Covidien, Boulder, CO, USA) starting from 4-6 cm to pylorus till the angle of His. The greater curvature was liberated up to the left crus of the diaphragm. The anterior and posterior wall of the stomach were transected with a 5 mm Ligasure device under the guidance of a 36 F bougie, starting 4-6 cm away from the pylorus and division of both gatric leaves headed vertically in the direction of angle of His. After completion of the gastric division, the resected specimen was removed through the mouth with the help of an intraoperative peroral endoscopy using an endoscopic snare. The remaining open anterior and posterior walls of the stomach was continiously sutured each other by 3/0 polypropylene sutures. The suture length was 20 cm.

All the trocars were 5 mm in size in the hand-sewn group. The surgical technique of the stapled group has been defined in detail before (2). In short, vertical gastrectomy was applied with a 60 mm. lineer stapler (Endo GIATM Ultra, Covidien) under the guidance of 36 F bougie. These procedures were done through three 12 mm and two 5 mm trocars, that were placed to the same locations with the hand-sewn group. The specimen in the stapler group were extracted from the left upper quadrant trocar site. No supportive material or suture was use to the staple lines. Methylene blue test was done and a drain was place in all case.

After 6-8 hours postoperatively, the patients were mobilized, thromboembolic stockings were kept for five days. A liquid diet was started on day one. Prophylaxis of deep vein thrombosis was continued for 15 days.

Conditions

Morbid Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hand-Sewn Sleeve Gastrectomy

Group Type: EXPERIMENTAL

Hand-Sewn Sleeve Gastrectomy

Intervention Type: PROCEDURE

After laparoscopic sleeve gastrectomy, gastrectomy site is hand-sewn with 3/0 polypropylene suture and the specimen is removed transorally.

Stapled Sleeve Gastrectomy

Group Type: ACTIVE_COMPARATOR

Stapled Sleeve Gastrectomy

Intervention Type: PROCEDURE

Laparoscopic sleeve gastrectomy is performed via 60 mm linear stapler (Endo GIATM Ultra, Covidien) .

Interventions

Hand-Sewn Sleeve Gastrectomy

After laparoscopic sleeve gastrectomy, gastrectomy site is hand-sewn with 3/0 polypropylene suture and the specimen is removed transorally.

Intervention Type: PROCEDURE

Stapled Sleeve Gastrectomy

Laparoscopic sleeve gastrectomy is performed via 60 mm linear stapler (Endo GIATM Ultra, Covidien) .

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of morbid obesity (body mass index over 40 kg/m2)
• Bariatric surgery must be the final decision of the obesity council.

Exclusion Criteria

• Patients under legal age (<18 years)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Serdar Kırmızı

M.D., Fellow at the Department of Gastroenterology Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014/33

Identifier Type: -

Identifier Source: org_study_id