NCT07148492

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
316

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

August 23, 2025

Last Update Submit

August 28, 2025

Conditions

Reflux Disease, Gastro-EsophagealVomiting, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Reflux disease

    The incidence of gastroesophageal reflux will be measured after surgery

    3 months and 6 months postoperatively

Secondary Outcomes (1)

  • Postoperative vomiting

    At 3 months and 6 months postoperatively

Study Arms (2)

Antireflux suture group

EXPERIMENTAL

This group consist of patients in whom antireflux suture is taken

Procedure: Antireflux suture

No Antireflux suture

EXPERIMENTAL

This group consist of patients in whom no antireflux suture is taken

Procedure: No Antireflux suture

Interventions

Antireflux suturePROCEDURE

Antireflux suture will be taken in this intervention group

Antireflux suture group
No Antireflux suturePROCEDURE

Antireflux suture will not be taken in this intervention group

No Antireflux suture

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing one anastomosis gastric bypass surgery

You may not qualify if:

  • Non consenting individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber teaching hospital

Peshawar, Khyberpukhtunkhwa, 25000, Pakistan

RECRUITING

MeSH Terms

Conditions

Gastroesophageal RefluxPostoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Central Study Contacts

Saeed Sarwar, MBBS

CONTACT

+923420973863saeedkmc2020@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 23, 2025

First Posted

August 29, 2025

Study Start

January 1, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Patients privacy may be breached

Locations

PA(1)