Naturally Banded Sleeve Gastrectomy

Obesity, Morbid Clinical Trial

Official title:

Naturally Banded Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05603338
• Other study ID #: fac.med 22.33
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: February 20, 2024

Study information

• Verified date: April 2024
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve

Description:

the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 20, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 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
• previous restrictive bariatric procedure

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Procedure:
• LSG with omental band
LSG with omental band
• LSG
just to do sleeve gastrectomy

Locations

Country	Name	City	State
Egypt	Minia university hospital	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effect on weight loss	the effect on weight loss determined by percentage of excess weight loss, percentage of total weight loss and change of BMI	12 months
Primary	the size of gastric pouch at one year	the size of gastric pouch after sleeve gastrectomy in cc at one year using gastric volumetric study	12 months
Secondary	the effect on comorbidities	change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer	12 monthts
Secondary	operative time	operative time in minutes from skin incision to skin closure	6 hours
Secondary	the incidences of complications	the incidences of complications including early complication like leak and bleeding and late complications like stricture diagnosed by vomiting's and imaging and GERD dignosed by symptoms and endoscopy	12 monthss