Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication

Minia University400 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

400

Conditions

Obesity, Morbid

Interventions

sleeve with plicationPROCEDURE

sleeve with plication

sleeve without plicationPROCEDURE

sleeve without plication

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

Faculty of medicine

Minya, Egypt

Minya university hospital

Minya, Egypt

Outcomes

Primary Outcomes

the incidence of postoperative stable line bleeding

early postoperative bleeding from stable line

Time frame: 2-24 hours

the incidence of stable line leakage

leak from stable line

Time frame: 1-30 days

Data from ClinicalTrials.gov

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