Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599489
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Management of Obese Patients With Gastroesophageal Reflux Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 endoscopy 24 hours PH monitoring nutritional and psychiatric evaluation Further exams andor consultations were performed when indicated The study design was a prospective randomized controlled study that received approval 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 05 unitKg24 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 patient 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 quadrant Retractor was inserted through the subxyphoid 10 mm trocar site to retract 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 Harmonic Scalpel Ethicon Endo-Surgery Inc Cincinnati OH to get a 4-cm tension-free intra-abdominal esophagus Posterior crural
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 patient 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 quadrant Retractor was inserted through the subxyphoid 10 mm trocar site to retract 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 Harmonic Scalpel Ethicon Endo-Surgery Inc Cincinnati OH to get a 4-cm tension-free intra-abdominal esophagus Posterior crural
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None