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CompletedNCT04144361Updated Mar 30, 2021

Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication

An interventional study of sleeve with plication and sleeve without plication in Obesity, Morbid, sponsored by Minia University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-03-30.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Obesity, Morbid

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Keywords

  • post sleeve gastrectomy leak
  • post sleeve gastrectomy
03

In context

Obesity, Morbid

922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.

This study's enrollment of 400 is above the median of 60 across 590 interventional studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    sleeve without plication

    sleeve gastrectomy on bougie 36 without plication

    Procedure: sleeve without plication

  • Active comparator
    sleeve with plication

    sleeve gastrectomy on bougie 42 without plication

    Procedure: sleeve with plication

Interventions

  • Proceduresleeve with plication

    sleeve with plication

  • Proceduresleeve without plication

    sleeve without plication

06

What researchers measure

Primary outcomes

  1. the incidence of postoperative stable line bleeding

    early postoperative bleeding from stable line

    Time frame: 2-24 hours

  2. the incidence of stable line leakage

    leak from stable line

    Time frame: 1-30 days

07

Study locations

2 sites
  • Faculty of medicine
    Minya, 61511, Egypt
  • Minya university hospital
    Minya, 61511, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04144361
Lead sponsor
Minia University
Responsible party
Alaa Mstafa Hassan Sewefy (Assistant professor and consultant of general surgery, Minia University) — Principal investigator
First posted
Oct 30, 2019
Start date
Dec 27, 2019
Primary completion
Aug 20, 2020
Completion
Aug 20, 2020
Last update
Mar 30, 2021

Study contacts

alaa M Sewefy
principal investigator · Minia University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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