Omental Banded Sleeve

• Sponsor: Minia University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05603338
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.5
• Patients Per Site Per Month: 14.8

Study Details

Study Description

Brief Summary

the idea is to use an omental flap as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve, RYGB and SASJ

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid	Procedure: LSG with omental band; Procedure: LSG	N/A

Detailed Description

the idea is to use an omental flap as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve, RYGB and SASJ. to avoid the complications and minimize the cost of the procedures

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Natural Banded Bariatric Procedures Using Omental Flap
• Actual Study Start Date: Nov 10, 2022
• Anticipated Primary Completion Date: Dec 15, 2023
• Anticipated Study Completion Date: Dec 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LSG just laparoscopic sleeve gastrectomy without banding	Procedure: LSG; just to do sleeve gastrectomy
Experimental: LSG with omental band laparoscopic sleeve gastrectomy with omental banding	Procedure: LSG with omental band; LSG with omental band

Outcome Measures

Primary Outcome Measures

1. the effect on weight loss [12 months]

   the effect on weight loss determined by percentage of excess weight loss, percentage of total weight loss and change of BMI

Secondary Outcome Measures

1. the effect on comorbidities [12 monthts]

   change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer

2. operative time [6 hours]

   operative time in minutes from skin incision to skin closure

3. the incidences of complications [12 monthss]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: 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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minia university hospital	Minya		Egypt	61511

Sponsors and Collaborators

• Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alaa Mstafa Hassan Sewefy, assistant professor of general surgery, Minia University
• ClinicalTrials.gov Identifier: NCT05603338
• Other Study ID Numbers: fac.med 22.33
• First Posted: Nov 2, 2022
• Last Update Posted: Dec 13, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity, Morbid

Study Results

No Results Posted as of Dec 13, 2022