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Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure

Study the Effectiveness and Safety of Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure, in Comparison to Laparoscopic Sleeve Gastrectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02878525
Acronym
LIGB
Enrollment
150
Registered
2016-08-25
Start date
2016-10-31
Completion date
2017-12-31
Last updated
2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Brief summary

The purpose of this study is to study the effectiveness of laparoscopic internal gastric banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy

Detailed description

In this study 190 morbidly obese patients will be included and will randomly assign into 2 groups, group 1 will be operated by laparoscopic internal gastric banding and group 2 by laparoscopic sleeve gastrectomy, the patients will be followed up for 1 year to evaluate the effectiveness and drawbacks of laparoscopic internal gastric banding in comparison to laparoscopic sleeve gastrectomy, the investigators preparing to submit our study protocol to our institution ethical committee for approval to start the study

Interventions

PROCEDURELaparoscopic internal gastric banding

Laparoscopic internal gastric banding

PROCEDURElaparoscopic sleeve gastrectomy

laparoscopic sleeve gastrectomy

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity * Approval to share in the study * Patients fit for laparoscopic surgery

Exclusion criteria

* Patient age less than 18 or more than 50 years old * Refusal to share in the study * Unfit for surgery * patients with gastroesophageal reflux disease clinically or by investigation

Design outcomes

Primary

MeasureTime frameDescription
safety of the technique4 weeksthe incidence of introperative and early postoperative complications

Secondary

MeasureTime frameDescription
operative time12 hoursthe operative time from skin to skin
Hospital stay30 daysTime of hospital stay
total cost16 weeksthe total cost of the technique by US dollar and its early complications
Metabolic effect6-12 monthsEffect of the procedure on blood sugar, serum lipid and hypertension

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026