The SILS Port from Covidien is an advanced surgical product designed to allow laparoscopic surgery through a single incision. This product is designed to give surgeons the ability to use multiple instruments with maximal maneuverability through a single incision in the patient’s umbilicus (belly button). The SILS Port leaves a hidden scar when used in the umbilicus and may minimize postoperative pain when compared to traditional open procedures.
The company recently announced interim results of its multicenter, international, prospective SILS™ Port laparoscopic cholecystectomy (removal of the gall bladder) post-market clinical study.
Dr. Marks is Associate Professor in the Department of Surgery and Director of Surgical Endoscopy at University Hospitals at Case Medical Center in Cleveland, OH. His team presented the interim topline results of the study during a podium presentation at SAGES 2011, the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons, which took place in San Antonio, TX from March 30 to April 2.
The prospective, randomized, controlled trial was designed to assess the feasibility and safety of performing gall bladder surgery via a single incision through the belly button with the aid of Covidien’s SILS Port. The study protocol allows participating surgeons to objectively document the scientific merit and the perceived advantages using the SILS Port through a single incision over a traditional laparoscopic technique (four incisions). The participating surgeons will monitor patients in the study for a year after the procedure to track their pain, quality of life and the cosmetic appearance of their abdomens.
All 200 patients have now been enrolled in the study; this data analysis includes preliminary results of 189 patients.
The 111 patients who underwent gall bladder surgery with the single incision approach reported significantly better cosmetic outcomes up to three months after their procedures, compared to the group whose surgeons used four laparoscopic ports. The pain scores between the two groups were within one point of each other on a 10 point visual analog scale rendering pain as clinically similar between the two groups. Surgeons, on average, took 12 minutes longer to perform the gall bladder surgery with the single-port approach (57 vs. 45 min., p<0.0001), but there was no difference in blood loss during the operation.
For more information, visit www.covidien.com