Standard Sleeve Pouch Versus Relatively Wide Pouch With P... | NCT04144361

Studies
Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication

NCT04144361

Sponsor

Minia University

Status

Completed

Last Update Posted

Mar 30, 2021Actual

Enrollment

400Actual

Phase

Not Applicable

Conditions

Obesity, Morbid

Interventions

sleeve with plication
sleeve without plication

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 2021

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

Dec 27, 2019Actual

Primary Completion Date

Aug 20, 2020Actual

Completion Date

Aug 20, 2020Actual

First Submitted Date

Oct 20, 2019

First Submission Date that Met QC Criteria

Oct 27, 2019

First Posted Date

Oct 30, 2019Actual

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 28, 2021

Last Update Posted Date

Mar 30, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alaa Mstafa Hassan Sewefy, Assistant professor and consultant of general surgery, Minia UniversityPrincipal Investigator

Lead Sponsor

Minia UniversityOTHER

Collaborators

Not provided

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

three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the aim is to test the effect of pilcation on the incidence of leaks and bleeding

Detailed Description

three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the primary outcomes is the incidence of leaks and bleeding which is the main nightmare of sleeve gastrectomy, secondary outcome operative time, weight loss and metabolic effect

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

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sleeve without plication	Experimental	sleeve gastrectomy on bougie 36 without plication	Procedure: sleeve without plication
sleeve with plication	Active Comparator	sleeve gastrectomy on bougie 42 without plication	Procedure: sleeve with plication

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sleeve with plication	Procedure	sleeve with plication	sleeve with plication

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the incidence of postoperative stable line bleeding	early postoperative bleeding from stable line	2-24 hours
the incidence of stable line leakage	leak from stable line	1-30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
patients fit for laparoscopic surgery
give approval to share in the study

Exclusion Criteria:

patients refused to share in the study
patients unfit for surgery
patients aged less than 18 and older than 60
patient with previous upper abdominal surgery either for obesity or other diseases
revisional bariatric procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 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	Minia University	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided