Management of Obese Patients With Gastroesophageal Reflux Disease .

NCT06599489 | Not Yet Recruiting

• 1 other identifier: obesity and GERD
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity and Obesity-related Medical Conditions

Keywords

obesity and reflux

Outcome Measures

Primary Outcomes (2)

• Weight loss and improvement of BMI

  BMI from above 35 kg/m2 to less,than 30. kg /m2to be less than 35 kg /m2

  6 momths

• Reflux symptoms

  Improvement of all symptoms of reflux disease

  6 months

Study Arms (2)

sleeve gastrectomy and cruroplasty

OTHER

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 and cruroplasty with ligamentum teres wrapping

OTHER

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

Interventions

surgery ..operation PROCEDURE

sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping

Also known as: sleeve gastrectomy and cruroplasty, ligamentum teres wrapping

sleeve gastrectomy and cruroplasty; sleeve gastrectomy and cruroplasty with ligamentum teres wrapping

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hossam Mahmoud Ibrahim: lead
• Assiut University: collaborator

MeSH Terms

Conditions

Obesity; Gastroesophageal Reflux

Interventions

Heller Myotomy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Sphincterotomy; Myotomy

Study Officials

• Assiut university

  Assiut University

  STUDY CHAIR

Central Study Contacts

Hossam Mahmoud Ibrahim

CONTACT

800-555-5555; Hh093579@gamil.com

Ahmed mo abdallah

CONTACT

aboabdalla¬-_333@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer at general surgery department

Model Details: operation surgical intervention

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share