Suspension of Falciform Ligament During Mini Gastric Bypass

March 13, 2020 updated by: Alaa Mstafa Hassan Sewefy, Minia University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61511
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: falciform ligament suspension
routine suspension of falciform ligament during mini gastric bypass,
Procedure: Falciform ligament suspension
routine of falciform ligament suspension during Mini gastric bypass
Active Comparator: No suspension
working without suspension of the falciform ligament
Procedure: no suspension
working without of falciform ligament suspension during Mini gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the difficulty of working during mini gastric bypass
Time Frame: 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
5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: 6 hours
duration of the operation from skin to skin
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

July 20, 2018

Study Completion (Actual)

July 20, 2018

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

January 24, 2018

First Posted (Actual)

January 31, 2018

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • fac.med.052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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