NCT05603338

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

October 28, 2022

Last Update Submit

April 11, 2024

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (2)

  • the effect on weight loss

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

    12 months

  • the size of gastric pouch at one year

    the size of gastric pouch after sleeve gastrectomy in cc at one year using gastric volumetric study

    12 months

Secondary Outcomes (3)

  • the effect on comorbidities

    12 monthts

  • operative time

    6 hours

  • the incidences of complications

    12 monthss

Study Arms (2)

LSG

ACTIVE COMPARATOR

just laparoscopic sleeve gastrectomy without banding

Procedure: LSG

LSG with omental band

EXPERIMENTAL

laparoscopic sleeve gastrectomy with omental banding

Procedure: LSG with omental band

Interventions

LSG with omental bandPROCEDURE

LSG with omental band

LSG with omental band
LSGPROCEDURE

just to do sleeve gastrectomy

LSG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia university hospital

Minya, 61511, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of general surgery

Study Record Dates

First Submitted

October 28, 2022

First Posted

November 2, 2022

Study Start

November 1, 2022

Primary Completion

January 30, 2024

Study Completion

February 20, 2024

Last Updated

April 12, 2024

Record last verified: 2024-04

Locations

EG(1)