Management of Obese Patients With Gastroesophageal Reflux Disease .

NCT ID: NCT06599489

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-12-01

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

Conditions

Obesity and Obesity-related Medical Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

surgery ..operation

Intervention Type: PROCEDURE

sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping

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.

Group Type: OTHER

surgery ..operation

Intervention Type: PROCEDURE

sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping

Interventions

surgery ..operation

sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping

Intervention Type: PROCEDURE

Other Intervention Names

sleeve gastrectomy and cruroplasty; ligamentum teres wrapping

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: collaborator

Hossam Mahmoud Ibrahim

OTHER

Sponsor Role: lead

Responsible Party

Hossam Mahmoud Ibrahim

Assistant lecturer at general surgery department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Assiut university

Role: STUDY_CHAIR

Assiut University

Central Contacts

Hossam Mahmoud Ibrahim

Role: CONTACT

Hh093579@gamil.com

800-555-5555

Ahmed mo abdallah

Role: CONTACT

aboabdalla¬-_333@aun.edu.eg

Other Identifiers

obesity and GERD

Identifier Type: -

Identifier Source: org_study_id