Antireflux Suture In One Anastomsis Gastric Bypass

August 28, 2025 updated by: Dr Saeed Sarwar, Khyber Teaching Hospital

Antireflux Suture In Laparoscopic One Anastomsis Gastric Bypass Surgery, A Randomised Control Trial

To prevent refulx symptoms in a type of bariatric surgery, a suture is taken.there is no enough evidence in support of or against the suture. our study aims to compare the symptoms of patients in whom the suture is taken and in those in whom it is not.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

316

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Khyberpukhtunkhwa
      • Peshawar, Khyberpukhtunkhwa, Pakistan, 25000
        • Recruiting
        • Khyber Teaching Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients undergoing one anastomosis gastric bypass surgery

Exclusion Criteria:

  • Non consenting individuals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antireflux suture group
This group consist of patients in whom antireflux suture is taken
Procedure: Antireflux suture
Antireflux suture will be taken in this intervention group
Experimental: No Antireflux suture
This group consist of patients in whom no antireflux suture is taken
Procedure: No Antireflux suture
Antireflux suture will not be taken in this intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reflux disease
Time Frame: 3 months and 6 months postoperatively
The incidence of gastroesophageal reflux will be measured after surgery
3 months and 6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative vomiting
Time Frame: At 3 months and 6 months postoperatively
Incidence of postoperative vomiting will be measured
At 3 months and 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khyber Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

August 23, 2025

First Submitted That Met QC Criteria

August 28, 2025

First Posted (Estimated)

August 29, 2025

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 528/DME/KMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patients privacy may be breached

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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