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OpenTrials
Completed

NCT Number: NCT02878525

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

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Minya, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic internal gastric banding

Procedure

Laparoscopic internal gastric banding

Laparoscopic sleeve gastrectomy

Procedure

laparoscopic sleeve gastrectomy

Primary outcomes

  1. safety of the technique

    Time frame: 4 weeks

    the incidence of introperative and early postoperative complications

Secondary outcomes

  1. operative time

    Time frame: 12 hours

    the operative time from skin to skin

  2. Hospital stay

    Time frame: 30 days

    Time of hospital stay

  3. total cost

    Time frame: 16 weeks

    the total cost of the technique by US dollar and its early complications

  4. Metabolic effect

    Time frame: 6-12 months

    Effect of the procedure on blood sugar, serum lipid and hypertension

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Acronym: LIGB

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 25, 2016
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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