Clinical trial NCT01844960: Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery
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
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Post-operative Pain
Post-operative Recovery
Keywords: Single Incision Surgery
SILS
Laparoscopic Gastric Band
Morbid Obesity
Bariatric Surgery
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain
timeFrame: first 10 days post-operatively
Secondary outcomes:
measure: Time to Discharge
timeFrame: Post-operative ward stay (estimated 2-8 hours)
Other outcomes:
measure: Conversion to laparoscopic or open surgery
timeFrame: Intra-operatively
measure: Intraoperative and post-operative complications
timeFrame: During surgery (intraoperative) and first 30 days (post-operative)
measure: Operative time
timeFrame: Skin incision to skin closure (estimated 45 -75 minutes)
measure: Cosmesis
timeFrame: 6 weeks to 6 months post-operatively
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
state: Greater London
Study officials:
affiliation: King's College Hospital NHS Trust
name: Ameet G Patel, MS FRCS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.