Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery

Surgery Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844960
• Other study ID #: 11/LO/1592
• Status: Completed
• Phase: N/A
• First received: August 6, 2012
• Last updated: September 1, 2015
• Start date: November 2011
• Est. completion date: October 2013

Study information

• Verified date: April 2013
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain
• Post-operative Recovery
• Surgery

Intervention

Procedure:
• Single Incision Gastric Band Insertion
Insertion of gastric band though single abdominal incision
• Multiple Incision Gastric Band Insertion
Insertion of gastric band though multiple abdominal incisions

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

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. Epub . — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Conversion to laparoscopic or open surgery		Intra-operatively	Yes
Other	Intraoperative and post-operative complications		During surgery (intraoperative) and first 30 days (post-operative)	Yes
Other	Operative time		Skin incision to skin closure (estimated 45 -75 minutes)	No
Other	Cosmesis		6 weeks to 6 months post-operatively	No
Primary	Pain		first 10 days post-operatively	No
Secondary	Time to Discharge		Post-operative ward stay (estimated 2-8 hours)	No