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RecruitingNCT05912920Updated Aug 1, 2023

Laparoscopic Natural Gastric Banding for Morbid Obesity

An interventional study of gastric band in Obesity, Morbid, sponsored by Minia University. Recruiting at 2 sites in Egypt. Open to participants aged 18 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 18 Years
Sex
All
01

Study summary

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

Read the detailed description

the round ligament or omental flap is used for gastric band instead of synesthetic band which had many complications that led to its abandon

02

Conditions studied

  • Obesity, Morbid
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 100 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    gastric band

    to do gastric banding use either round ligament or omental flap

    Procedure: gastric band

  • Active comparator
    sleeve gastrectomy

    to do sleeve gastrectomy as standard

    Procedure: gastric band

Interventions

  • Proceduregastric band

    gastric band

06

What researchers measure

Primary outcomes

  1. %EWL

    percentage of excess weight loss at one year

    Time frame: 12 months

Secondary outcomes

  1. complications rate

    the incidence of complications

    Time frame: 12 months

07

Study locations

2 of 2 sites recruiting
  • Faculty of medicine
    Minya, 61511, Egypt
    Recruiting
  • Minia university hospital
    Minya, 61511, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05912920
Lead sponsor
Minia University
Responsible party
Alaa Mstafa Hassan Sewefy (prof., Minia University) — Principal investigator
First posted
Jun 22, 2023
Start date
Jul 1, 2023
Primary completion
Aug 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Aug 1, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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