Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery

Study Overview
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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.

Official Title
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A Prospective Double Blinded Randomised Control Trial Comparing Laparoscopic Single Incision Versus Multiple Incision Adjustable Gastric Band Surgery in Patients With Morbid Obesity

Conditions
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Surgery, Post-operative Pain, Post-operative Recovery

Intervention / Treatment
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* Procedure: Single Incision Gastric Band Insertion
* Procedure: Multiple Incision Gastric Band Insertion


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multiple Incision Gastric Band Insertion<br>Current standard surgical approach for laparoscopic gastric band insertion | Procedure: Multiple Incision Gastric Band Insertion<br>* Insertion of gastric band though multiple abdominal incisions<br>|
| Experimental: Single Incision Gastric Band Insertion<br>New surgical approach for gastric band insertion | Procedure: Single Incision Gastric Band Insertion<br>* Insertion of gastric band though single abdominal incision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | first 10 days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Discharge |  | Post-operative ward stay (estimated 2-8 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single Incision Surgery, SILS, Laparoscopic Gastric Band, Morbid Obesity, Bariatric Surgery