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

Morbid Obesity Clinical Trial

— LIGB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878525
• Other study ID #: fac.med.018
• Status: Completed
• Phase: N/A
• First received: August 21, 2016
• Last updated: January 31, 2018
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Weight Loss

Intervention

Procedure:
• Laparoscopic internal gastric banding
Laparoscopic internal gastric banding
• laparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Minya
Egypt	Minia university hospital	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety of the technique	the incidence of introperative and early postoperative complications	4 weeks
Secondary	operative time	the operative time from skin to skin	12 hours
Secondary	Hospital stay	Time of hospital stay	30 days
Secondary	total cost	the total cost of the technique by US dollar and its early complications	16 weeks
Secondary	Metabolic effect	Effect of the procedure on blood sugar, serum lipid and hypertension	6-12 months