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Comparison of Laparoscopic Traditional and Knotless Sutures

NCT02720718 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-03-03

No results posted yet for this study

Summary

Background

Excess weight and obesity is the fifth leading risk factor for global death. Bariatric surgery is considered as the only effective long-term treatment for morbid obesity. Laparoscopic Roux-en-Y gastric bypass is one of the best surgical procedures, since it achieves excellent long-term results with a low complication rate. Intestinal anastomosis is a very complex and time-consuming procedure in laparoscopy, mainly due to the difficulties of knotting the suture in a limited working area. Barbed sutures may enhance this procedure by eliminating the need for knot tying.

Objective The aim of this study is to compare the safety and efficacy of knotless barbed sutures (Stratafix) and continuous sutures (Vicryl) for closing the gastrojejunal and jejunojejunal anastomosis in obese patients undergoing gastric bypass.

Study design

This is a prospective randomized study. Patients will be randomly assigned to one of two groups: traditional suture group or knotless suture group. Randomization will be realized by sealed envelopes according to a computer-generated sequence of random numbers, which will be opened for the surgeon just before starting the anastomosis. During the surgery the gastrojejunal and jejunojejunal anastomoses will be performed with a stapler (Echelon 45 Endopath) and closed with a traditional (Vicryl) or knotless (Stratafix Unidirectional) suture. The same surgeon, experienced and specialized in laparoscopic gastric bypass technique, will perform all procedures.

Study population

Two hundred patients undergoing laparoscopic Roux-en-Y gastric bypass.

Main study parameters/endpoints

The primary outcome measure will be the rate of anastomosis-related complications (leakage, bleeding, gastric fistula, anastomotic stenosis) at 4 weeks and at 6 months post-op (safety). The secondary outcome measure will be the time spent on closing the gastrojejunal and jejunojejunal anastomosis (efficacy).

Conditions

  • Anastomosis, Roux-en-Y
  • Surgical Operation With Anastomosis, Bypass or Graft

Interventions

DEVICE

Stratafix

DEVICE

Vicryl

Sponsors & Collaborators

  • AZ St.-Dimpna Geel

    lead OTHER

Principal Investigators

  • Ben Gys, md · AZ Sint Dimpna, Geel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-09-30
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02720718 on ClinicalTrials.gov