Comparison of the Incidence of Internal Hernia and LUQ Pain Following Classic Gastric Bypass Surgery in Patients with Jejunojejunal Defect Closure Using Purse-String Versus Linear Suturing Techniques
To determine the incidence of internal hernia in patients undergoing classic gastric bypass surgery with closure of the jejunojejunal defect using the purse string suture technique.
To determine the incidence of internal hernia in patients undergoing classic gastric bypass surgery with closure of the jejunojejunal defect using the linear suture technique.
To determine the incidence of LUQ pain in patients undergoing classic gastric bypass surgery with closure of the jejunojejunal defect using the purse string suture technique
To determine the incidence of LUQ pain in patients undergoing classic gastric bypass surgery with closure of the jejunojejunal defect using the linear suture technique.
To determine the operative time in patients undergoing classic gastric bypass surgery with closure of the jejunojejunal defect using the purse string suture technique.
To determine the operative time in patients undergoing classic gastric bypass surgery with closure of the jejunojejunal defect using the linear suture technique.
Design
Sample size: 102
single-blind randomized clinical trial with SPSS
Multi center
Settings and conduct
Department of Surgery at Isfahan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Patients who underwent Roux-en-Y Gastric Bypass surgery in hospitals affiliated with Isfahan University of Medical Sciences between 2024 and 2025 and were diagnosed with internal hernia and followed up for at least one year will be included.
Intervention groups
Group A: the jejunojejunal defect was closed using a purse string suture technique. Group B: the jejunojejunal defect was closed using a linear suture technique.
Main outcome variables
incidence of internal hernia, pain, patients' satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260425069164N1
Registration date:2026-05-13, 1405/02/23
Registration timing:prospective
Last update:2026-05-13, 1405/02/23
Update count:0
Registration date
2026-05-13, 1405/02/23
Registrant information
Name
Negin Alihosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 2289
Email address
iamnegin.hosseini@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-06-05, 1405/03/15
Expected recruitment end date
2027-06-05, 1406/03/15
Actual recruitment start date
2026-06-05, 1405/03/15
Actual recruitment end date
2027-06-05, 1406/03/15
Trial completion date
2027-07-06, 1406/04/15
Scientific title
Comparison of the Incidence of Internal Hernia and LUQ Pain Following Classic Gastric Bypass Surgery in Patients with Jejunojejunal Defect Closure Using Purse-String Versus Linear Suturing Techniques
Public title
Comparison of the Incidence of Internal Hernia and LUQ Pain Following Classic Gastric Bypass Surgery in Patients with Jejunojejunal Defect Closure Using Purse-String Versus Linear Suturing Techniques
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who underwent Roux-en-Y Gastric Bypass surgery in hospitals affiliated with Isfahan University of Medical Sciences between 2024 and 2025.
Patients who were diagnosed with internal hernia and followed up for at least one year.
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
102
Actual sample size reached:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using a block randomization table generated by SPSS version 26 (block size 4) to maintain balance between the two groups over time.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be blinded in this study. Before the surgery the surgeon will choose a card between A and B blindly and the method of intervention will be chosen.Group A will consist of patients undergoing purse-string suturing, and Group B will consist of patients undergoing linear running suturing.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Department of Medical Ethics, Ground Floor, School of Medicine, Building No. 3, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2026-02-06, 1404/11/17
Ethics committee reference number
IR.MUI.MED.REC.1404.448
Health conditions studied
1
Description of health condition studied
Gastric Bypass Surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incidence of internal hernia
Timepoint
In one year after the surgery
Method of measurement
Clinical judgment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in whom the jejunojejunal defect was closed using a purse-string suture technique.
Category
Treatment - Surgery
2
Description
Intervention group: Patients in whom the jejunojejunal defect was closed using a linear suture technique.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Hamid Melali
Street address
No 173, Shamsabadi St, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
813561347
Phone
+98 31 3312 5000
Email
info@sinahospital.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Melali
Street address
Medical School of Isfahan University of Medical Sciences, Hezarjerib St., Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Email
hamidmelali@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Melali
Position
Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Medical School, Isfahan University of Medical Sciences, Hezarjerib St., Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
009133197463
Email
hamidmelali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Melali
Position
Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Medical School, Isfahan University of Medical Sciences, Hezarjerib St., Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
009133197463
Email
hamidmelali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Melali
Position
Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Medical School, Isfahan University of Medical Sciences, Hezarjerib St., Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
009133197463
Email
hamidmelali@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only data of the primary outcomes will be shared.
When the data will become available and for how long
After publication
To whom data/document is available
Researchers, academic institutions, journals
Under which criteria data/document could be used
All requests should be sent to the corresponding author.
From where data/document is obtainable
Email the corresponding author
What processes are involved for a request to access data/document
After contacting the corresponding author, he will process and verify the request and in case of approval, the data will be emailed to you.