SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.
The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.
In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.
Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.
Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m2, said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.
SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.
BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.
Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.
Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.
Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."
The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."