St. Luke’s-Roosevelt Hospital Center in New York is currently recruiting patients to take part in a clinical trial that will compare outcomes of single incision laparoscopic gastric banding versus conventional five port laparoscopic gastric banding. This study will be one of the first to examine these two minimally invasive approaches side-by-side and determine if laparoscopic gastric banding can be made even better by using one incision instead of five.
For this study, surgeons will make just one incision at the belly button in patients who are selected for the single incision laparoscopic surgery (SILS). Patients who are selected for conventional laparoscopic gastric banding will receive the traditional five small incisions in the abdominal wall.
With single incision laparoscopic surgery (SILS), the supposed benefits include reduced scarring and accelerated healing, although these have not yet been proven. The theory is that with fewer incisions, it is better cosmetically, the pain may be less, and recovery may be quicker.
This surgical method is an advanced procedure that requires an experienced surgeon who is highly skilled in laparoscopic surgery. In order to perform the surgery through one incision, surgeons must use special laparoscopic instruments and access ports. The first device specifically indicated for multiple instrument access to the abdomen through a single incision is the SILS (TM) Port by Covidian.
Currently, only a few bariatric centers are performing single incision laparoscopic surgery for adjustable gastric banding surgery. The SILS technique has also been used by a few bariatric surgeons for sleeve gastrectomy (gastric sleeve). With the anticipated benefits, it is expected that the number of bariatric surgeons who are trained in single incision laparoscopic surgery will increase in the future.
The clinical trial being conducted by St. Luke’s-Roosevelt Hospital Center states a study start date of December 2009 and an estimated primary completion date of December 2010.