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NCT Number: NCT06599489

Management of Obese Patients With Gastroesophageal Reflux Disease .

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

surgery ..operation

Procedure

sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping

Other names: sleeve gastrectomy and cruroplasty, ligamentum teres wrapping

Primary outcomes

  1. 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

  2. Reflux symptoms

    Time frame: 6 months

    Improvement of all symptoms of reflux disease

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed mo abdallah

CONTACT

aboabdalla¬[email protected]

Hossam Mahmoud Ibrahim

CONTACT

[email protected]

800-555-5555

Sponsors and collaborators

Lead sponsor

Hossam Mahmoud Ibrahim

Other

Collaborators

  • Assiut University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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