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Effect of Routine Anterior Crural Repair in De-Novo Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy

NCT04884074 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-05-12

No results posted yet for this study

Summary

The purpose of the study is to evaluate the superiority of anterior crural repair during sleeve gastrectomy over no repair in decreasing the incidence of gastroesophageal reflux disease.

Conditions

  • Obesity
  • Gastro Esophageal Reflux Disease

Interventions

PROCEDURE

Standard Sleeve Gastrectomy plus Anterior Crural Repair

The procedure is performed in a similar fashion as standard sleeve gastrectomy. After gastric mobilization is completed as standard sleeve gastrectomy, the anterior phrenoesophageal ligament is divided and distal 3cm esophagus is mobilized. A Mid-Sleeve tube (40Fr) is inserted per-orally by the anesthetist and the hiatus opening is closed with 2/0 non-absorbable suture over the bougie anterior to the esophagus. The hiatus repair was sized by comfortably placement a dissection forceps adjacent to the esophagus without tension. Sleeve gastrectomy is then performed as the standard technique.

PROCEDURE

Standard sleeve gastrectomy (SSG, the control group)

The procedure is performed in French position with a standard 5-port approach and a pneumoperitoneum not exceeding 15mmHg. The greater omentum is then completely detached from the greater curvature of stomach using either ultrasonic or bipolar shear device. All adhesion between posterior gastric wall and pancreatic capsule is freed and the cardia is completely free with left crura completely exposed. A Mid-Sleeve tube (40Fr) is inserted per-orally by the anesthetist with its balloon tip reaching the gastric antrum and insufflated with 50cc of air. Sleeve gastrectomy is then performed using laparoscopic linear staplers, starting from a point 5-6cm proximal to the pylorus up cardia at about 1cm lateral to the angle of His, along the Mid-sleeve tube which is lying against the lesser curve of stomach. The staple line is reinforced with absorbable sutures. Distal stomach is anchored at retroperitoneum with non-absorbable stitch.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2024-12-31
Completion
2025-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04884074 on ClinicalTrials.gov