NCT01844960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

September 2, 2015

Status Verified

April 1, 2013

Enrollment Period

1.5 years

First QC Date

August 6, 2012

Last Update Submit

September 1, 2015

Conditions

SurgeryPost-operative PainPost-operative Recovery

Keywords

Single Incision SurgerySILSLaparoscopic Gastric BandMorbid ObesityBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • Pain

    first 10 days post-operatively

Secondary Outcomes (1)

  • Time to Discharge

    Post-operative ward stay (estimated 2-8 hours)

Other Outcomes (4)

  • Conversion to laparoscopic or open surgery

    Intra-operatively

  • Intraoperative and post-operative complications

    During surgery (intraoperative) and first 30 days (post-operative)

  • Operative time

    Skin incision to skin closure (estimated 45 -75 minutes)

  • +1 more other outcomes

Study Arms (2)

Multiple Incision Gastric Band Insertion

ACTIVE COMPARATOR

Current standard surgical approach for laparoscopic gastric band insertion

Procedure: Multiple Incision Gastric Band Insertion

Single Incision Gastric Band Insertion

EXPERIMENTAL

New surgical approach for gastric band insertion

Procedure: Single Incision Gastric Band Insertion

Interventions

Single Incision Gastric Band InsertionPROCEDURE

Insertion of gastric band though single abdominal incision

Single Incision Gastric Band Insertion
Multiple Incision Gastric Band InsertionPROCEDURE

Insertion of gastric band though multiple abdominal incisions

Multiple Incision Gastric Band Insertion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, Greater London, SE5 9RS, United Kingdom

Location

Related Publications (7)

  • 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.

    PMID: 20721587BACKGROUND

  • 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.

    PMID: 20652322BACKGROUND

  • 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.

    PMID: 19288157BACKGROUND

  • 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.

    PMID: 19579051BACKGROUND

  • 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.

    PMID: 19969508BACKGROUND

  • 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.

    PMID: 20174950BACKGROUND

  • 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.

    PMID: 21890429BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeObesity, Morbid

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Ameet G Patel, MS FRCS

    King's College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2012

First Posted

May 3, 2013

Study Start

November 1, 2011

Primary Completion

May 1, 2013

Study Completion

October 1, 2013

Last Updated

September 2, 2015

Record last verified: 2013-04

Locations

GB(1)