Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication

Sponsor

Minia University (Other)

Overall Status

Completed

CT.gov ID

NCT04144361

Collaborator

(none)

400

Enrollment

Locations

Arms

7.8

Actual Duration (Months)

200

Patients Per Site

25.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid	Procedure: sleeve with plication Procedure: sleeve without plication	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Outcomes of Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication

Actual Study Start Date :

Dec 27, 2019

Actual Primary Completion Date :

Aug 20, 2020

Actual Study Completion Date :

Aug 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sleeve without plication sleeve gastrectomy on bougie 36 without plication	Procedure: sleeve without plication sleeve without plication
Active Comparator: sleeve with plication sleeve gastrectomy on bougie 42 without plication	Procedure: sleeve with plication sleeve with plication

Arm

Intervention/Treatment

Experimental: sleeve without plication

sleeve gastrectomy on bougie 36 without plication

Procedure: sleeve without plication

sleeve without plication

Active Comparator: sleeve with plication

sleeve gastrectomy on bougie 42 without plication

Procedure: sleeve with plication

sleeve with plication

Outcome Measures

Primary Outcome Measures

the incidence of postoperative stable line bleeding [2-24 hours]
early postoperative bleeding from stable line
the incidence of stable line leakage [1-30 days]
leak from stable line

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine	Minya		Egypt	61511
2	Minya university hospital	Minya		Egypt	61511

Sponsors and Collaborators

Minia University

Investigators

Principal Investigator: alaa M Sewefy, Minia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT04144361

Other Study ID Numbers:

fac,med 19.32

First Posted:

Oct 30, 2019

Last Update Posted:

Mar 30, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alaa Mstafa Hassan Sewefy, Assistant professor and consultant of general surgery, Minia University

post sleeve gastrectomy leak

post sleeve gastrectomy

Additional relevant MeSH terms:

Obesity, Morbid

Study Results

No Results Posted as of Mar 30, 2021