Surgery Clinical Trial
— SIMISOfficial title:
A Prospective Double Blinded Randomised Control Trial Comparing Laparoscopic Single Incision Versus Multiple Incision Adjustable Gastric Band Surgery in Patients With Morbid Obesity
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 |
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College Hospital NHS Foundation Trust | London | Greater London |
Lead Sponsor | Collaborator |
---|---|
King's College Hospital NHS Trust |
United Kingdom,
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
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 |
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