Antireflux Suture In One Anastomsis Gastric Bypass | NCT07148492

Studies
Antireflux Suture In One Anastomsis Gastric Bypass

NCT07148492

Sponsor

Khyber Teaching Hospital

Status

Recruiting

Last Update Posted

Aug 29, 2025Actual

Enrollment

316Estimated

Phase

Not Applicable

Conditions

Reflux Disease, Gastro-Esophageal
Vomiting, Postoperative

Interventions

Antireflux suture
No Antireflux suture

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Sep 30, 2025Estimated

Completion Date

Sep 30, 2025Estimated

First Submitted Date

Aug 23, 2025

First Submission Date that Met QC Criteria

Aug 28, 2025

First Posted Date

Aug 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2025

Last Update Posted Date

Aug 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

316Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Antireflux suture	Procedure	Antireflux suture will be taken in this intervention group	Antireflux suture group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing one anastomosis gastric bypass surgery

Exclusion Criteria:

Non consenting individuals

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Saeed Sarwar, MBBS	Contact	+923420973863		saeedkmc2020@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Khyber teaching hospital	Recruiting	Peshawar	Khyberpukhtunkhwa	25000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Patients privacy may be breached

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided