Management of Obese Patients With Gastroesophageal Reflux Disease .

Not Applicable

Not yet recruiting

• Conditions: Obesity and Obesity-related Medical Conditions

• Registration Number: NCT06599489
• Lead Sponsor: Hossam Mahmoud Ibrahim

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-08-30
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-13
• Last Update Submitted: 2024-09-13
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-10-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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