Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery (SIMIS)

September 1, 2015 updated by: King's College Hospital NHS Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain
Time Frame: first 10 days post-operatively
first 10 days post-operatively

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Conversion to laparoscopic or open surgery
Time Frame: Intra-operatively
Intra-operatively
Intraoperative and post-operative complications
Time Frame: During surgery (intraoperative) and first 30 days (post-operative)
During surgery (intraoperative) and first 30 days (post-operative)
Operative time
Time Frame: Skin incision to skin closure (estimated 45 -75 minutes)
Skin incision to skin closure (estimated 45 -75 minutes)
Cosmesis
Time Frame: 6 weeks to 6 months post-operatively
6 weeks to 6 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Investigators

  • Principal Investigator: Ameet G Patel, MS FRCS, King's College Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 6, 2012

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/LO/1592

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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