NCT05912920

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

2 active sites

Status
unknown

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

June 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

June 11, 2023

Last Update Submit

July 29, 2023

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • %EWL

    percentage of excess weight loss at one year

    12 months

Secondary Outcomes (1)

  • complications rate

    12 months

Study Arms (2)

gastric band

EXPERIMENTAL

to do gastric banding use either round ligament or omental flap

Procedure: gastric band

sleeve gastrectomy

ACTIVE COMPARATOR

to do sleeve gastrectomy as standard

Procedure: gastric band

Interventions

gastric bandPROCEDURE

gastric band

gastric bandsleeve gastrectomy

Eligibility Criteria

Age18 Years - 18 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 (2)

Faculty of medicine

Minya, 61511, Egypt

RECRUITING

Minia university hospital

Minya, 61511, Egypt

RECRUITING

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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof.

Study Record Dates

First Submitted

June 11, 2023

First Posted

June 22, 2023

Study Start

July 1, 2023

Primary Completion

August 1, 2024

Study Completion

October 1, 2024

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations

EG(2)