Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication

Obesity, Morbid Clinical Trial

Official title:

Outcomes of Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144361
• Other study ID #: fac,med 19.32
• Status: Completed
• Phase: N/A
• Start date: December 27, 2019
• Est. completion date: August 20, 2020

Study information

• Verified date: March 2021
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 20, 2020
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Procedure:
• sleeve with plication
sleeve with plication
• sleeve without plication
sleeve without plication

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Minya
Egypt	Minya university hospital	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of postoperative stable line bleeding	early postoperative bleeding from stable line	2-24 hours
Primary	the incidence of stable line leakage	leak from stable line	1-30 days