Suspension of Falciform Ligament During Mini Gastric Bypass | NCT03417089

Studies
Suspension of Falciform Ligament During Mini Gastric Bypass

NCT03417089

Sponsor

Minia University

Status

Completed

Last Update Posted

Mar 17, 2020Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Upper GIT Surgery

Interventions

Falciform ligament suspension
no suspension

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Jul 20, 2018Actual

Completion Date

Jul 20, 2018Actual

First Submitted Date

Jan 18, 2018

First Submission Date that Met QC Criteria

Jan 24, 2018

First Posted Date

Jan 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2020

Last Update Posted Date

Mar 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
falciform ligament suspension	Experimental	routine suspension of falciform ligament during mini gastric bypass,	Procedure: Falciform ligament suspension
No suspension	Active Comparator	working without suspension of the falciform ligament	Procedure: no suspension

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Falciform ligament suspension	Procedure	routine of falciform ligament suspension during Mini gastric bypass	falciform ligament suspension

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the difficulty of working during mini gastric bypass	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alaa M Sewefy, MD	Minia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine		Minya		61511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided