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

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic internal gastric banding
laparoscopic sleeve gastrectomy
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of medicine
  • Minia university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic internal gastric banding

Laparoscopic sleeve gastrectomy

Arm Description

Laparoscopic internal gastric banding

Laparoscopic sleeve gastrectomy

Outcomes

Primary Outcome Measures

safety of the technique
the incidence of introperative and early postoperative complications

Secondary Outcome Measures

operative time
the operative time from skin to skin
Hospital stay
Time of hospital stay
total cost
the total cost of the technique by US dollar and its early complications
Metabolic effect
Effect of the procedure on blood sugar, serum lipid and hypertension

Full Information

First Posted
August 21, 2016
Last Updated
January 31, 2018
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT02878525
Brief Title
Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic internal gastric banding
Arm Type
Experimental
Arm Description
Laparoscopic internal gastric banding
Arm Title
Laparoscopic sleeve gastrectomy
Arm Type
Active Comparator
Arm Description
Laparoscopic sleeve gastrectomy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic internal gastric banding
Intervention Description
Laparoscopic internal gastric banding
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sleeve gastrectomy
Intervention Description
laparoscopic sleeve gastrectomy
Primary Outcome Measure Information:
Title
safety of the technique
Description
the incidence of introperative and early postoperative complications
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
operative time
Description
the operative time from skin to skin
Time Frame
12 hours
Title
Hospital stay
Description
Time of hospital stay
Time Frame
30 days
Title
total cost
Description
the total cost of the technique by US dollar and its early complications
Time Frame
16 weeks
Title
Metabolic effect
Description
Effect of the procedure on blood sugar, serum lipid and hypertension
Time Frame
6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of medicine
City
Minya
ZIP/Postal Code
61511
Country
Egypt
Facility Name
Minia university hospital
City
Minya
ZIP/Postal Code
61511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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