Evaluation the efficacy of anterior cruroplasty versus posterior cruroplasty in improvement of Gastroesophageal reflux disease (GERD)after One Anastomosis Gastric Bypass (OAGB)
Evaluation the efficacy of anterior cruroplasty vs posterior .cruroplasty in improvement of Gastroesophageal reflux disease (GERD)after One-Anastomosis Gastric Bypass (OAGB)
Design
Clinical trial, with parallel groups, single-blind, randomized, on 120 patients
Settings and conduct
Rasool-e Akram, Modarres, and Firouzgar hospitals in Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria were: 40<BMI<50, 18<age<65, Primary bariatric surgery
OAGB Surgical Procedure, BP Limb of 150 cm, Anastomosis diameter 4 cm
Symptomatic clinical GERD before OAGB, GERD grade A, B, C in pre-op endoscopy, Any size of hiatal hernia. Exclusion criteria were: High risk of anesthesia after heart and lung counseling, Diagnosing the surgeon based on the high risk of surgery, Lack of mental health: Serious psychological problem including psychosis and severe, uncontrollable depression at the discretion of the specialist, and Barrett's esophagus in pre-op endoscopy.
Intervention groups
1- Intervention group: One anastomosis gastric bypass without cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament.
2- Intervention group: One anastomosis gastric bypass with anterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament. Then an anterior cruroplasty is performed with Ethibond 2-0.
3- Intervention group: One anastomosis gastric bypass with posterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament. Then an posterior cruroplasty is performed with Ethibond 2-0.
Main outcome variables
Status of Gastroesophageal Reflux Disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190128042520N4
Registration date:2022-11-23, 1401/09/02
Registration timing:prospective
Last update:2022-11-23, 1401/09/02
Update count:1
Registration date
2022-11-23, 1401/09/02
Registrant information
Name
Mohammad Kermansaravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8809 5451
Email address
kermansaravi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of anterior cruroplasty versus posterior cruroplasty in improvement of Gastroesophageal reflux disease (GERD)after One Anastomosis Gastric Bypass (OAGB)
Public title
Evaluation the efficacy of diaphragmatic hernia repair in improvement of Gastroesophageal reflux disease (GERD)after One Anastomosis Gastric Bypass (OAGB)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
40<BMI<50
18<age<65
Primary bariatric surgery
OAGB Surgical Procedure
BP Limb of 150 cm
Anastomosis diameter 4 cm
Symptomatic clinical GERD before OAGB
GERD grade A, B, C in pre-op endoscopy
Any size of hiatal hernia
Exclusion criteria:
High risk of anesthesia after heart and lung counseling
Diagnosing the surgeon based on the high risk of surgery
Lack of mental health: Serious psychological problem including psychosis and severe uncontrollable depression at the discretion of the specialist
Barrett's esophagus in pre-op endoscopy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use Block Randomization method with six block sizes. Excel software and rand() function will be used to prepare random order inside each block. We will have 3 groups of 40 people. When the intervention of each participant is determined, then a unique four-digit code will be assigned to the person (concealment). This number is the randomization code of the participant and the person will be identified with this number until the end of the study. A chain of 120 random allocations for use in the first phase of the study will be kept by the main investigator.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients are not aware about the type of surgery, but all types will describe before performing surgery and the aim of study completely clarify for them. This issue that the efficacy of these three methods on postoperative reflux is unknown, completely describe for the patients and they include in study after obtaining the informed consent.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-11-16, 1401/08/25
Ethics committee reference number
IR.IUMS.REC.1401.646
Health conditions studied
1
Description of health condition studied
Gastro-esophageal reflux disease
ICD-10 code
K21
ICD-10 code description
Gastro-esophageal reflux disease
Primary outcomes
1
Description
Gastroesophageal Reflux Disease
Timepoint
Before surgery and 7 months after surgery
Method of measurement
Upper GI Endoscopy (esophagogastroduodenoscopy)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: One anastomosis gastric bypass without cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament.
Category
Treatment - Surgery
2
Description
Intervention group 2: One anastomosis gastric bypass with anterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament. Then an anterior cruroplasty is performed with Ethibond 2-0.
Category
Treatment - Surgery
3
Description
Intervention group 3: One anastomosis gastric bypass with posterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament. Then an posterior cruroplasty is performed with Ethibond 2-0.