Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication

Outcomes of Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04144361

Enrollment

400

Registered

2019-10-30

Start date

2019-12-27

Completion date

2020-08-20

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid

Keywords

post sleeve gastrectomy leak, post sleeve gastrectomy

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

Interventions

PROCEDUREsleeve with plication

sleeve with plication

PROCEDUREsleeve without plication

sleeve without plication

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026