Naturally Banded Sleeve Gastrectomy

NCT ID: NCT05603338

Last Updated: 2024-04-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-02-20

Brief Summary

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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

Detailed Description

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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

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

DOUBLE

Participants Outcome Assessors

Study Groups

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LSG

just laparoscopic sleeve gastrectomy without banding

Group Type ACTIVE_COMPARATOR

LSG

Intervention Type PROCEDURE

just to do sleeve gastrectomy

LSG with omental band

laparoscopic sleeve gastrectomy with omental banding

Group Type EXPERIMENTAL

LSG with omental band

Intervention Type PROCEDURE

LSG with omental band

Interventions

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LSG with omental band

LSG with omental band

Intervention Type PROCEDURE

LSG

just to do sleeve gastrectomy

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

60 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

assistant professor of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Minia university hospital

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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fac.med 22.33

Identifier Type: -

Identifier Source: org_study_id

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