NCT06298942

Brief Summary

to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver)

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

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

February 21, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

February 21, 2024

Last Update Submit

March 1, 2024

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (2)

  • total cost

    total operative cost in Egyptian pound (LE)

    12 hours

  • food intolerance

    food intolerance at one year food tolerance arabic score questionnaire

    1 year

Secondary Outcomes (3)

  • %EWL

    1 year

  • complications rate

    1 year

  • improvement of comorbidities

    1 year

Study Arms (2)

natural band

EXPERIMENTAL

to use an round ligament as a natural band in stead of synesthetic band with sleeve gastrectomy

Procedure: natural band

silicone band

ACTIVE COMPARATOR

to use a synesthetic band with sleeve gastrectomy

Procedure: silicone band

Interventions

natural bandPROCEDURE

to use the round ligament as a natural band in stead of synesthetic band with sleeve gastrectomy

natural band
silicone bandPROCEDURE

to use synesthetic band with sleeve gastrectomy

silicone band

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

You may not qualify if:

  • patients refused to share in the study
  • patients unfit for surgery
  • patients aged less than 18 and older than 65
  • patient with previous upper abdominal surgery either for obesity or other diseases
  • revisional bariatric procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor & consultant of general surgery,

Study Record Dates

First Submitted

February 21, 2024

First Posted

March 7, 2024

Study Start

March 15, 2024

Primary Completion

June 15, 2025

Study Completion

July 15, 2025

Last Updated

March 7, 2024

Record last verified: 2024-03