Laparoscopic Natural Gastric Banding for Morbid Obesity

NCT ID: NCT05912920

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-10-01

Brief Summary

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

Detailed Description

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

Conditions

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Obesity, Morbid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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gastric band

to do gastric banding use either round ligament or omental flap

Group Type EXPERIMENTAL

gastric band

Intervention Type PROCEDURE

gastric band

sleeve gastrectomy

to do sleeve gastrectomy as standard

Group Type ACTIVE_COMPARATOR

gastric band

Intervention Type PROCEDURE

gastric band

Interventions

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gastric band

gastric band

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Mstafa Hassan Sewefy

prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine

Minya, , Egypt

Site Status RECRUITING

Minia university hospital

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Alaa M Sewefy, MD

Role: primary

+201006448805

M

Role: backup

Alaa M Sewefy, MD

Role: primary

+201006448805

Other Identifiers

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fac.med 23.25

Identifier Type: -

Identifier Source: org_study_id

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