Prospective Randomized Trial Comparing Laparoendoscopic Single-Site (less) Surgery with Traditional Multiple Port Laparoscopic Surgery for Adjustable Gastric Banding

John N Afthinos, MD, Koji Park, MD, Ninan Koshy, MBBS, James J McGinty, MD, Julio A Teixeira, MD FACS. St. Luke’s-Roosevelt Hospital Center, NY

Introduction:
Laparoendoscopic single-site (LESS) surgery for adjustable gastric band placement has been described in several case series, demonstrating safety and feasibility. To date, no prospective trials have evaluated the clinical outcomes of LESS gastric banding. We report the early results of a prospective, randomized trial comparing LESS surgery with traditional multiport laparoscopic surgery for the placement of an adjustable gastric band.

Methods:
From January 2010 to September 2010, 10 patients were randomized to undergo LESS gastric band and 9 patients underwent multiport gastric banding. Patients were blinded to the procedure by the application of identical surgical dressings at the end of the operation. Exclusion criteria included significant hepatomegaly, radiographic evidence of hiatal hernia, connective tissue disease, steroid use, or history of open upper abdominal surgery. Data was collected on operative time, postoperative pain, postoperative narcotic consumption, and length of stay. Patients were followed for complications during the first postoperative year. Cosmetic assessment and quality of life scores were also collected.

Results:
Of the 28 patients meeting criteria, a total of 9 (32%) refused: 5 patients cited fear of greater postoperative pain with a multiport procedure, 2 patients requested LESS surgery for cosmetic reasons, and 2 patients believed that LESS surgery would facilitate wound healing. The remaining 19 patients (68%) underwent randomization to either LESS or multiport gastric banding. Mean BMI was 43 kg/m² in the LESS group and 45 kg/m² in the multiport group. Mean operative times were 69 minutes and 52 minutes, respectively (p=0.027). The total dose of postoperative hydromorphone via patient controlled anesthesia (PCA) device averaged 2.6 mg of in the LESS group and 2.0 mg in the multiport group (p=0.496). The mean duration of PCA use in the LESS group was 15.8 hours (range 6-23 hours) and 16.6 hours (range 13-24 hours) in the multiport group (p=0.712). The mean pain score on a 1-10 scale in the LESS group at postoperative hour 1 was 4 (range 0-5) and 4 (range 2-6) in the multiport group (p=0.884). The mean pain score at postoperative hour 12 in the LESS group was 2 (range 0-4) and 1 (range 0-4) in the multiport group (p=0.189). The mean length of stay in the LESS group was 22.1 hours (range,16-26 hours) and 25.2 hours (range 18-47 hours) in the multiport group (p=0.285). There were no conversions from LESS surgery to multiport surgery. One patient in the LESS group had a port infection 4 months later and elected to remove the entire band. One patient in the multiport group required a port revision 5 months post-operatively due to port dislodgement.

Discussion:
The preliminary results of this prospective randomized trial indicate that LESS surgery for adjustable gastric banding is safe and feasible for selected patients. One patient in each group required reoperation several months after initial placement of the gastric band. No statistically significant differences were seen in terms of postoperative pain, postoperative narcotic use and hospital length of stay. Further studies are needed to assess the long term outcomes between the two approaches.


Session: SS12
Program Number: S067

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