Mechanical versus suture fixation of the port in adjustable gastric banding procedures: a prospective randomized blinded study

Abstract

Laparoscopic adjustable gastric band port placement can require 9-25% of total implantation time. Prolonged port fixation combined with extended wound manipulation results in an elevated incidence of port-related complications (infection, port tension, pain, rotation). This study compared port fixation using a novel applier to traditional fixation using nonresorbable sutures. From Dec 2005 to March 2006, 50 patients were enrolled into a prospective randomized study. Intra- and postoperative outcomes of placing the Swedish Adjustable Gastric Band((R)) (SAGB) Realize with Velocity port and fixation device (group A) were compared to those of the SAGB with its titanium suture-fixation port (group B). Patient characteristics, port implantation duration, incision length, postoperative port-site pain [via visual analogue scale (VAS)], pain medication, and complications were recorded. Minimum follow-up was 12 months (three visits). Postoperative evaluation was performed by an investigator not involved in the surgery. Patient groups were comparable in age, sex, and body mass index. In group A versus group B, mean port implantation time was lower (53.5 +/- 13.1 versus 451.3 +/- 84.9 s, p < 0.0001), port-site skin incision was longer (mean 4.1 +/- 0.2 versus 3.1 +/- 0.2 cm, p < 0.0001), and postoperative opioid consumption was less (mean 1.3 versus 3.0 units, p < 0.01). Group A reported less mean pain on the VAS (3.2 versus 3.8, p < 0.01); 0/25 group A versus 3/25 group B patients required hypnotics. There were no discernible differences between groups in hospitalization (mean 2.9 days), nursing requirements, or pain at 3, 6, and 12 months. In group A, no patient required reoperation for a port complication; two port rotations occurred in group B (NS). Velocity mechanical port applier fixation is superior in efficiency to port suture fixation, safely increasing the speed to port implant from nearly 8 min to under 1 min and decreasing total operative time by 19%. Port applier fixation trends to reduction of major complications and statistically significantly lessens the minor complication of port-site pain.