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NCT06298942 Clinical Trial

Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy

Obesity, Morbid Clinical Trial

Official title:
Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06298942
Other study ID # fac.med.24.9
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 15, 2024
Est. completion date July 15, 2025

Study information
Verified date March 2024
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver)

Description:

to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver) as regard weight loss, complications rat and cost

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 250
Est. completion date July 15, 2025
Est. primary completion date June 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 65 - patient with previous upper abdominal surgery either for obesity or other diseases - revisional bariatric procedures

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• natural band
to use the round ligament as a natural band in stead of synesthetic band with sleeve gastrectomy
• silicone band
to use synesthetic band with sleeve gastrectomy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Minia University

Outcome
Type Measure Description Time frame Safety issue
Primary total cost total operative cost in Egyptian pound (LE) 12 hours
Primary food intolerance food intolerance at one year food tolerance arabic score questionnaire 1 year
Secondary %EWL percentage of weight loss at one year measured as (initial weight - follow-up weight) / (initial weight - bodyweight at a BMI of 25 kg/ m2) x 100 1 year
Secondary complications rate the incidence of early and late complications according to Clavien-Dindo (CD) 1 year
Secondary improvement of comorbidities the incidence of improvement of comorbidities 1 year
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