Suspension of Falciform Ligament During Mini Gastric Bypass

Not Applicable

Completed

• Conditions: Upper GIT Surgery
• Interventions: Procedure: Falciform ligament suspension; Procedure: no suspension

• Registration Number: NCT03417089
• Lead Sponsor: Minia University

Brief Summary

The falciform ligament is hanging down in the upper abdomen and usually impede the work during laparoscopic upper GIT surgery, especially in obese patient, so the aim of this study is to evaluate the impact of routine suspension of falciform ligament during mini gastric bypass, which is advanced laparoscopic procedure, by comparing the outcomes in 2 groups of patient in the fist group the investigators will routinely suspend the falciform ligament and the other group the investigators will working without suspension

Detailed Description

The falciform ligament is hanging down in the upper abdomen and usually impede the work during laparoscopic upper GIT surgery, especially in obese patient, so the aim of this study is to evaluate the impact of routine suspension of falciform ligament during mini gastric bypass, which is advanced laparoscopic procedure, by comparing the outcomes in 2 groups of patient in the fist group the investigators will routinely suspend the falciform ligament and the other group the investigators will working without suspension

Study Timeline

• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Study Start: 2018-02-01
• Primary Completion: 2018-07-20
• Study Completion: 2018-07-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-13
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Morbidly obese patient with BMI more than 40 with or without co-morbidity
• Morbidly obese patient with BMI more than 35 with co-morbidity

Exclusion Criteria

• Unfit patients for laparoscopic sleeve gastrectomy
• Patients refuse to share in the study
• Patients that already on PPI due to any indications
• Revisional surgery for obesity
• Previous upper abdominal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
falciform ligament suspension	Falciform ligament suspension	routine suspension of falciform ligament during mini gastric bypass,
No suspension	no suspension	working without suspension of the falciform ligament

Primary Outcome Measures

Name	Time	Method
the difficulty of working during mini gastric bypass	5 hours	difficulty of working during mini gastric bypass assessed by many parameters like number of clashing of instruments per one operations and operative time

Secondary Outcome Measures

Name	Time	Method
operative time	6 hours	duration of the operation from skin to skin

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Minya, Egypt