Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-10-31

Brief Summary

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A double blinded randomised control trial comparing the differences between laparoscopic single incision versus multiple port bariatric surgery in morbidly obese patients (BMI\>35). Single incision surgery is a new minimally invasive surgical technique requiring the surgeon to operate through one small single incision and is virtually scarless. The traditional laparoscopic approach to abdominal surgery is through multiple small incisions (4-7 ports) across the whole abdomen. This study seeks to identify the risks, benefits and costs of the adjustable gastric band insertion via single incision and multiple incision within the morbidly obese patient group.

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Detailed Description

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Conditions

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Surgery Post-operative Pain Post-operative Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Multiple Incision Gastric Band Insertion

Current standard surgical approach for laparoscopic gastric band insertion

Group Type ACTIVE_COMPARATOR

Multiple Incision Gastric Band Insertion

Intervention Type PROCEDURE

Insertion of gastric band though multiple abdominal incisions

Single Incision Gastric Band Insertion

New surgical approach for gastric band insertion

Group Type EXPERIMENTAL

Single Incision Gastric Band Insertion

Intervention Type PROCEDURE

Insertion of gastric band though single abdominal incision

Interventions

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Single Incision Gastric Band Insertion

Insertion of gastric band though single abdominal incision

Intervention Type PROCEDURE

Multiple Incision Gastric Band Insertion

Insertion of gastric band though multiple abdominal incisions

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Morbidly obese patients, BMI ≥35 kg/m2
* Undergoing gastric band surgery
* Undergone a pre-weight loss surgery risk assessment
* Fit for anaesthesia and surgery
* Fulfil day surgery criteria
* Full understanding of bariatric procedure, with informed consent of the risks and benefits of laparoscopic single incision and multiple incision surgery

Exclusion Criteria

* Pregnancy
* History of portal hypertension
* Previous gastric surgery or large hiatus hernia
* Previous laparotomy or bariatric surgery
* Weight \>150kg (day surgery limit)
* Unwilling to consider surgical treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No