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Management of Obese Patients With Gastroesophageal Reflux Disease .

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06599489
Enrollment
100
Registered
2024-09-19
Start date
2024-10-01
Completion date
2026-12-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity and Obesity-related Medical Conditions

Keywords

obesity and reflux

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

Interventions

PROCEDUREsurgery ..operation

sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping

Sponsors

Assiut University
CollaboratorOTHER
Hossam Mahmoud Ibrahim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

operation surgical intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Weight loss and improvement of BMI6 momthsBMI from above 35 kg/m2 to less,than 30. kg /m2to be less than 35 kg /m2
Reflux symptoms6 monthsImprovement of all symptoms of reflux disease

Contacts

Primary ContactHossam Mahmoud Ibrahim
Hh093579@gamil.com800-555-5555
Backup ContactAhmed mo abdallah
aboabdalla¬-_333@aun.edu.eg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026