Trials Sponsors Conditions Drugs Pricing

Conditions

Morbid Obesity Requiring Bariatric Surgery

Keywords

Class IV Obese PatientsBanded versus Non-Banded Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

Total Weight Loss (TWL)
Total Weight Loss between the 2 groups (in kilograms)
Measured at 6, 12, 24 and 36 months postoperatively

Secondary Outcomes (9)

Change in associated medical problems
6, 12, 24, and 36 months.
Change in associated medical problems
6, 12, 24, and 36 months.
Change in associated medical problems
6, 12, 24, and 36 months.
Change in associated medical problems
6, 12, 24, and 36 months.
Complications
post operative, 12, 24, and 36 months
+4 more secondary outcomes

Study Arms (2)

Banded Group

ACTIVE COMPARATOR

Placement of a 1.5 x 5.5 cm polypropylene band

Procedure: Band

Non-Banded Group

PLACEBO COMPARATOR

Standard laparoscopic sleeve gastrectomy

Procedure: Non-Band

Interventions

BandProcedure

Laparoscopic sleeve gastrectomy with the placement of a 1.5 x 5.5 cm polypropylene band around the proximal gastric pouch to enhance restriction.

Banded Group

Non-BandProcedure

Standard laparoscopic sleeve gastrectomy where approximately 75-80% of the stomach is resected to form a tubular structure

Non-Banded Group

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Adults aged 18-60 years
BMI ≥ 50 kg/m² (Class IV obesity)

Sponsors & Collaborators

General Committee of Teaching Hospitals and Institutes, Egypt
Governmentlead

Study Sites (1)

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, 21531, Egypt

MeSH Terms

Interventions

Chromosome BandingChloride-Bicarbonate Antiporters

Intervention Hierarchy (Ancestors)

Cytogenetic AnalysisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisStaining and LabelingHistocytological Preparation TechniquesHistological TechniquesInvestigative TechniquesGenetic TechniquesAntiportersIon Pumps

Study Officials

Mohamed Ashour, Ph.D. (Professor)
The surgical department of Medical Research Institute Hospital, Alexandria University
PRINCIPAL INVESTIGATOR

Enrollment

219 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, CARE PROVIDER
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of General surgery

Study Record Dates

First Submitted

July 17, 2025

First Posted

August 3, 2025

Banded Versus Non-Banded Sleeve in Class IV Obese Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Banded Group

Non-Banded Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Banded Group

Non-Banded Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations