Laparoscopic Natural Gastric Banding for Morbid Obesity

• Sponsor: Minia University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05912920
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

to do gastric banding using round ligament or omental flap instead of synesthetic band

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid	Procedure: gastric band	N/A

Detailed Description

the round ligament or omental flap is used for gastric band instead of synesthetic band which had many complications that led to its abandon

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Laparoscopic Natural Gastric Banding for Management of Morbid Obesity
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: gastric band to do gastric banding use either round ligament or omental flap	Procedure: gastric band; gastric band
Active Comparator: sleeve gastrectomy to do sleeve gastrectomy as standard	Procedure: gastric band; gastric band

Outcome Measures

Primary Outcome Measures

1. %EWL [12 months]

   percentage of excess weight loss at one year

Secondary Outcome Measures

1. complications rate [12 months]

   the incidence of complications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 18 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	Faculty of medicine	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, prof., Minia University
• ClinicalTrials.gov Identifier: NCT05912920
• Other Study ID Numbers: fac.med 23.25
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 23, 2023
• Last Verified: Jun 1, 2023

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

Study Results

No Results Posted as of Jun 23, 2023