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Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication

M

Minia University

Status

Completed

Conditions

Obesity, Morbid

Treatments

Procedure: sleeve without plication
Procedure: sleeve with plication

Study type

Interventional

Funder types

Other

Identifiers

NCT04144361
fac,med 19.32

Details and patient eligibility

About

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

Full 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

Enrollment

400 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

400 participants in 2 patient groups

sleeve without plication
Experimental group
Description:
sleeve gastrectomy on bougie 36 without plication
Treatment:
Procedure: sleeve without plication
sleeve with plication
Active Comparator group
Description:
sleeve gastrectomy on bougie 42 without plication
Treatment:
Procedure: sleeve with plication

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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