Management of Obese Patients With Gastroesophageal Reflux Disease .
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: surgery ..operation.
- Who it may be relevant to
- Registry conditions: Obesity and Obesity-related Medical Conditions. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sleeve Gastrectomy With Crural Repair With or Without Ligamentum Teres Wrapping in Obese Patients With Gastroesophageal Reflux Disease .Arandomized Controlled Trial
Overview
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
- Procedure surgery ..operation
sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping
Primary outcome measures
- Weight loss and improvement of BMI [Time frame: 6 momths]
- Reflux symptoms [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06599489 · obesity and GERD