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

Primary Purpose

Surgery, Post-operative Pain, Post-operative Recovery

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Single Incision Gastric Band Insertion
Multiple Incision Gastric Band Insertion
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring Single Incision Surgery, SILS, Laparoscopic Gastric Band, Morbid Obesity, Bariatric Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King's College Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Multiple Incision Gastric Band Insertion

Single Incision Gastric Band Insertion

Arm Description

Current standard surgical approach for laparoscopic gastric band insertion

New surgical approach for gastric band insertion

Outcomes

Primary Outcome Measures

Pain

Secondary Outcome Measures

Time to Discharge

Full Information

First Posted
August 6, 2012
Last Updated
September 1, 2015
Sponsor
King's College Hospital NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01844960
Brief Title
Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery
Acronym
SIMIS
Official Title
A Prospective Double Blinded Randomised Control Trial Comparing Laparoscopic Single Incision Versus Multiple Incision Adjustable Gastric Band Surgery in Patients With Morbid Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Post-operative Pain, Post-operative Recovery
Keywords
Single Incision Surgery, SILS, Laparoscopic Gastric Band, Morbid Obesity, Bariatric Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiple Incision Gastric Band Insertion
Arm Type
Active Comparator
Arm Description
Current standard surgical approach for laparoscopic gastric band insertion
Arm Title
Single Incision Gastric Band Insertion
Arm Type
Experimental
Arm Description
New surgical approach for gastric band insertion
Intervention Type
Procedure
Intervention Name(s)
Single Incision Gastric Band Insertion
Intervention Description
Insertion of gastric band though single abdominal incision
Intervention Type
Procedure
Intervention Name(s)
Multiple Incision Gastric Band Insertion
Intervention Description
Insertion of gastric band though multiple abdominal incisions
Primary Outcome Measure Information:
Title
Pain
Time Frame
first 10 days post-operatively
Secondary Outcome Measure Information:
Title
Time to Discharge
Time Frame
Post-operative ward stay (estimated 2-8 hours)
Other Pre-specified Outcome Measures:
Title
Conversion to laparoscopic or open surgery
Time Frame
Intra-operatively
Title
Intraoperative and post-operative complications
Time Frame
During surgery (intraoperative) and first 30 days (post-operative)
Title
Operative time
Time Frame
Skin incision to skin closure (estimated 45 -75 minutes)
Title
Cosmesis
Time Frame
6 weeks to 6 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ameet G Patel, MS FRCS
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20721587
Citation
Patel AG, Murgatroyd B, Carswell K, Belgaumkar A. Fundus-first transumbilical single-incision laparoscopic cholecystectomy with a cholangiogram: a feasibility study. Surg Endosc. 2011 Mar;25(3):954-7. doi: 10.1007/s00464-010-1240-6. Epub 2010 Aug 19.
Results Reference
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PubMed Identifier
20652322
Citation
Patel AG, Belgaumkar AP, James J, Singh UP, Carswell KA, Murgatroyd B. Video. Single-incision laparoscopic left lateral segmentectomy of colorectal liver metastasis. Surg Endosc. 2011 Feb;25(2):649-50. doi: 10.1007/s00464-010-1237-1. Epub 2010 Jul 22.
Results Reference
background
PubMed Identifier
19288157
Citation
Teixeira J, McGill K, Binenbaum S, Forrester G. Laparoscopic single-site surgery for placement of an adjustable gastric band: initial experience. Surg Endosc. 2009 Jun;23(6):1409-14. doi: 10.1007/s00464-009-0411-9. Epub 2009 Mar 14.
Results Reference
background
PubMed Identifier
19579051
Citation
de la Torre RA, Satgunam S, Morales MP, Dwyer CL, Scott JS. Transumbilical single-port laparoscopic adjustable gastric band placement with liver suture retractor. Obes Surg. 2009 Dec;19(12):1707-10. doi: 10.1007/s11695-009-9896-5.
Results Reference
background
PubMed Identifier
19969508
Citation
Nguyen NT, Slone J, Reavis K. Comparison study of conventional laparoscopic gastric banding versus laparoendoscopic single site gastric banding. Surg Obes Relat Dis. 2010 Sep-Oct;6(5):503-7. doi: 10.1016/j.soard.2009.10.001. Epub 2009 Nov 10.
Results Reference
background
PubMed Identifier
20174950
Citation
Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2010 Aug;24(8):1842-8. doi: 10.1007/s00464-010-0887-3. Epub 2010 Feb 20.
Results Reference
background
PubMed Identifier
21890429
Citation
Patel AG, Murgatroyd B, Ashton WD. Single incision laparoscopic adjustable gastric banding: 111 cases. Surg Obes Relat Dis. 2012 Nov-Dec;8(6):747-51. doi: 10.1016/j.soard.2011.06.013. Epub 2011 Jul 13.
Results Reference
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Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery

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