Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication
Outcomes of Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication
1 other identifier
interventional
400
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2019
CompletedStudy Start
First participant enrolled
December 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2020
CompletedMarch 30, 2021
March 1, 2021
8 months
October 20, 2019
March 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
the incidence of postoperative stable line bleeding
early postoperative bleeding from stable line
2-24 hours
the incidence of stable line leakage
leak from stable line
1-30 days
Study Arms (2)
sleeve without plication
EXPERIMENTALsleeve gastrectomy on bougie 36 without plication
sleeve with plication
ACTIVE COMPARATORsleeve gastrectomy on bougie 42 without plication
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (2)
Faculty of medicine
Minya, 61511, Egypt
Minya university hospital
Minya, 61511, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
alaa M Sewefy
Minia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor and consultant of general surgery
Study Record Dates
First Submitted
October 20, 2019
First Posted
October 30, 2019
Study Start
December 27, 2019
Primary Completion
August 20, 2020
Study Completion
August 20, 2020
Last Updated
March 30, 2021
Record last verified: 2021-03