By George Ochoa

In a head-to-head comparison, patients undergoing single-incision laparoscopic cholecystectomy had a significantly higher rate of hernia formation at one-year follow-up than those having standard four-port laparoscopy.

Only one of 81 patients who received standard laparoscopy developed a hernia (1.2%) versus 10 of 119 patients (8.4%) who underwent the single-incision procedure (P=0.03).

“I was somewhat surprised by the results,” the study’s lead author, Jeffrey M. Marks, MD, FACS, FASGE, told General Surgery News. “But as you make incisions larger, there is a greater consequence of hernia.” Dr. Marks is professor of surgery at University Hospitals Case Medical Center, Cleveland.

Steven Schwaitzberg, MD, FACS, chief of surgery, Cambridge Health Alliance, and associate professor, Harvard Medical School, Boston, who was not involved in the study, said in an interview: “In many ways, this is a landmark paper because it’s going to drive clinical practice.”

The study, published in the Journal of the American College of Surgeons (2013;216:1037-1047) was sponsored by Covidien, manufacturer of the SILS Port, a device used in single-incision laparoscopic cholecystectomy. According to Dr. Marks, Covidien was “fully transparent, and above all wanted to assure that they didn’t influence the study.”

In an invited commentary accompanying the study, David W. Rattner, MD, FACS, wrote, “Covidien Inc., and the authors are to be congratulated both for performing the study properly and publishing results that were not necessarily what the corporate sponsor might have hoped for.”

In the prospective, multicenter, single-blinded, controlled trial, 200 patients were randomized to single-incision (n=119) or standard (n=81) laparoscopic cholecystectomy. All patients at the 10 sites had biliary colic with documented gallstones or polyps, or had biliary dyskinesia. The primary end points were feasibility and safety. Follow-up at 12 months was completed by 100 patients (84%) in the single-incision group and 64 (79%) in the standard laparoscopy group.

Adverse events and severe adverse events did not differ significantly between the two groups. Four wound-related complications were reported in the standard laparoscopy group (4.9%) and 14 were reported in the single-incision group (11.7%), but the difference was not statistically significant (P=0.13). Pain scores were higher in the single-incision group than for standard laparoscopy at nearly all measured points, but the difference in most cases was not statistically significant.

Cosmesis scores favored single-incision over standard laparoscopy at all time points (P<0.0004). Physical quality-of-life scores favored standard laparoscopy over single-incision laparoscopy at some time points (day 3, P=0.01; one week, P=0.03; one month, P=0.03), but were equivalent at all other time points. The two groups did not differ with respect to mental quality-of-life scores. At all time points, more than 92% of patients preferred single-incision laparoscopy if they needed a cholecystectomy again (P<0.0001).

Although the study is now closed, Dr. Marks, who is also director of surgical endoscopy and program director, Case Medical Center, said, “It would be nice to reassess the patients in three and five years, and see if the difference in hernia formation is greater or if it has equilibrated.”

For now, Dr. Schwaitzberg, who is also past president, Society of American Gastrointestinal and Endoscopic Surgeons, said, “The data support the continued use of multiport surgery for cholecystectomy since the hernia rate is lower.”

Dr. Marks noted, “Cosmesis was improved for the single-port group. That is one of our goals with any surgery, but an effective surgery with minimal complications is the greater goal.”

Drs. Marks and Schwaitzberg reported no relevant financial conflicts of interest.