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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Obesity, Morbid

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