Management of Obese Patients With Gastroesophageal Reflux Disease .

September 13, 2024 updated by: Hossam Mahmoud Ibrahim

Sleeve Gastrectomy With Crural Repair With or Without Ligamentum Teres Wrapping in Obese Patients With Gastroesophageal Reflux Disease .Arandomized Controlled Trial

The aim of this study is to evaluate the efficacy Sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping for management of morbidly obese patients with concomitant reflux symptoms.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients underwent a preoperative work-up including history and physical examination, routine laboratory investigations, ECG, chest radiography, pulmonary function tests, abdominal ultrasonography, and barium swallow, upper GIT endos¬copy, 24 hours PH monitoring, nutritional, and psychiat¬ric evaluation. Further exams and/or consultations were performed when indicated. The study design was a pro¬spective randomized controlled study that received ap¬proval from the ethics committee in relevant hospitals. All the patients gave an informed written consent All patients had a written informed consent of the two types laparoscopic procedures of obesity, Prophylactic anticoagulant medications will be given to all patients in the form of subcutaneous Clexane 0.5 unit/Kg/24. An Intensive care unit (ICU) bed will be reserved for all patients the night of operation with the decision of transfer left to the postoperative recovery assessment.

According to the patient selection, all patients will be divided into two groups as follows:

Group (A): Patients will do Laparoscopic sleeve gastrectomy with crural repair. Under a general anesthesia, the patient was placed in the split-leg position with the surgeon standing between the legs and the assistant on the left-hand side of the pa¬tient. A veress needle was used to create the pneumoperi-toneum. Three 12-mm trocars were inserted in the upper abdomen (one on the right, two on the left side) and one 5-mm trocar was inserted laterally in the left-upper quad¬rant. Retractor was inserted through the subxyphoid 10 mm trocar site to re¬tract the liver (five to seven Trocars always used) The hiatal hernia sac containing the proximal stomach was reduced. Distal esophagus and gastroesophageal junction were mobilized by using a laparoscopic Harmon¬ic Scalpel (Ethicon Endo-Surgery Inc., Cincinnati, OH) to get a 4-cm tension-free intra-abdominal esophagus. Pos¬terior crural

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact Backup

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-60 years.
  • Both sexes.
  • BMI ≥ 40 or ≥ 35 with co-morbidity.with reflux symptoms .
  • Failure of non-surgical treatment.
  • Patients with hiatus hernia .
  • Absence of endocrinal or psychological disorders.
  • Failure of non surgical treatment
  • Non sweat eaters
  • Patients with no previous upper GIT surgeries

Exclusion Criteria:

  • Presence of endocrinal or psychological disorders.
  • Morbidly obese patients with no reflux symptoms
  • sweat eaters
  • Patients with barrett,s oesophagus ,
  • Patient with bad general condition

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: sleeve gastrectomy and cruroplasty
Under a general anesthesia. Three 12-mm trocars were inserted in the upper abdomen and one 5-mm trocar was inserted laterally in the left-upper quad¬rant. Retractor was inserted through the subxyphoid 10 mm trocar site to re¬tract the liver (five to seven Trocars always used) . The hiatal hernia sac containing the proximal stomach was reduced. Distal esophagus and gastroesophageal junction were mobilized by using a laparoscopic Harmon¬ic Scalpelto get a 4-cm tension-free intra-abdominal esophagus. Pos¬terior crural repair was performed with three interrupt¬ed
Procedure: surgery ..operation
sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping
Other Names:
  • sleeve gastrectomy and cruroplasty
  • ligamentum teres wrapping
Other: sleeve gastrectomy and cruroplasty with ligamentum teres wrapping

sleeve gastrectomy and cruroplasty with ligamentum teres wrapping for cardiopexy for morbidly obese patients with reflux symptomspatients will Laparoscopic sleeve gastrectomy with crural repair with ligamentum teres wrapping .the same as in group (A) in addition to ligamentum teres wrapping behind lower end of oesophagus and fixed to anterior wall of stomach with interrupted sutures .

The mean follow up period was eight months .clinical outcomes were also evaluated in term of GERD symptoms improvement or resolution .interruption of anti reflux medications and xray evidence of HH recurrence.
Procedure: surgery ..operation
sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping
Other Names:
  • sleeve gastrectomy and cruroplasty
  • ligamentum teres wrapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss and improvement of BMI
Time Frame: 6 momths
BMI from above 35 kg/m2 to less,than 30. kg /m2to be less than 35 kg /m2
6 momths
Reflux symptoms
Time Frame: 6 months
Improvement of all symptoms of reflux disease
6 months

Collaborators and Investigators

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

Sponsor

Hossam Mahmoud Ibrahim

Collaborators

Assiut University

Investigators

  • Study Chair: Assiut university, Assiut University

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 (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

September 13, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 13, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • obesity and GERD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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