Single-incision gall bladder surgery as safe and effective as standard multi-port cholecystectomy

Covidien (NYSE: COV), a leading global provider of healthcare products, today announced interim results of its multicenter, international, prospective SILS™ Port laparoscopic cholecystectomy (removal of the gall bladder) post-market clinical study.

“Covidien is dedicated to collaborating with the surgical community to generate evidence that supports the use of its innovative products to help patients achieve better outcomes”

"The interim results of this study show that single-incision gall bladder surgery appears to be as safe and effective as standard multi-port cholecystectomy. In addition, patients may view the cosmetic results as superior when compared to the traditional four-port laparoscopic approach," said primary investigator Jeffrey M. Marks, M.D., FACS. "This prospective study is designed to confirm that a single-incision procedure is safe and to determine whether the perceived benefits will hold true across a wider population of patients. If the final results remain in line with this interim analysis, I expect a growing number of patients concerned about the appearance of their abdomens to seek out surgeons who offer them the choice of a major operation with fewer incisions."

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.

"Covidien is dedicated to collaborating with the surgical community to generate evidence that supports the use of its innovative products to help patients achieve better outcomes," said Michael Tarnoff, M.D., Chief Medical Officer, Covidien. "This is one of the largest prospective studies of the SILS technique conducted to date in the U.S. Covidien's surgical devices business is firmly committed to bring products like the SILS Port to market that aim to reduce the surgical footprint."