Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery

Not Applicable

Completed

• Conditions: Surgery; Post-operative Recovery; Post-operative Pain
• Interventions: Procedure: Multiple Incision Gastric Band Insertion; Procedure: Single Incision Gastric Band Insertion

• Registration Number: NCT01844960
• Lead Sponsor: King's College Hospital NHS Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-08-06
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-29
• Primary Completion: 2013-05
• Study First Posted: 2013-05-03
• Study Completion: 2013-10
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple Incision Gastric Band Insertion	Multiple Incision Gastric Band Insertion	Current standard surgical approach for laparoscopic gastric band insertion
Single Incision Gastric Band Insertion	Single Incision Gastric Band Insertion	New surgical approach for gastric band insertion

Primary Outcome Measures

Name	Time	Method
Pain	first 10 days post-operatively

Secondary Outcome Measures

Name	Time	Method
Time to Discharge	Post-operative ward stay (estimated 2-8 hours)

Trial Locations

Locations (1)

King's College Hospital NHS Foundation Trust; 🇬🇧 London, Greater London, United Kingdom