Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy

TY - JOUR

T1 - Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy

AU - Jørgensen, Lars Nannestad

AU - Rosenberg, J

AU - Al-Tayar, H

AU - Assaadzadeh, S

AU - Helgstrand, F

AU - Bisgaard, T

N1 - © 2014 BJS Society Ltd. Published by John Wiley & Sons Ltd.

PY - 2014/3

Y1 - 2014/3

N2 - Background There are no randomized studies that compare outcomes after single-incision (SLC) and conventional multi-incision (MLC) laparoscopic cholecystectomy under an optimized perioperative analgesic regimen. Methods This patient- and assessor-blinded randomized three-centre clinical trial compared SLC and MLC in women admitted electively with cholecystolithiasis. Outcomes were registered on the day of operation (day 0), on postoperative days 1, 2, 3 and 30, and 12 months after surgery. Blinding of the patients was maintained until day 3. The primary endpoint was pain on movement measured on a visual analogue scale, reported repeatedly by the patient until day 3. Results The intention-to-treat population comprised 59 patients in the SLC and 58 in the MLC group. There was no significant difference between the groups with regard to any of the pain-related outcomes, on-demand administration of opioids or general discomfort. Median duration of surgery was 32·5 min longer in the SLC group (P < 0·001). SLC was associated with a reduced incidence of vomiting on day 0 (7 versus 22 per cent; P = 0·019). The incidences of wound-related problems were comparable. One patient in the SLC group experienced a biliary leak requiring endoscopic retrograde cholangiopancreatography. The rates of incisional hernia at 12-month follow-up were 2 per cent in both groups. Cosmetic rating was significantly improved after SLC at 1 and 12 months (P < 0·001). Conclusion SLC did not significantly diminish early pain in a setting with optimized perioperative analgesic patient care. SLC may reduce postoperative vomiting. Registration number: NCT01268748 (http://www. clinicaltrials.gov).

AB - Background There are no randomized studies that compare outcomes after single-incision (SLC) and conventional multi-incision (MLC) laparoscopic cholecystectomy under an optimized perioperative analgesic regimen. Methods This patient- and assessor-blinded randomized three-centre clinical trial compared SLC and MLC in women admitted electively with cholecystolithiasis. Outcomes were registered on the day of operation (day 0), on postoperative days 1, 2, 3 and 30, and 12 months after surgery. Blinding of the patients was maintained until day 3. The primary endpoint was pain on movement measured on a visual analogue scale, reported repeatedly by the patient until day 3. Results The intention-to-treat population comprised 59 patients in the SLC and 58 in the MLC group. There was no significant difference between the groups with regard to any of the pain-related outcomes, on-demand administration of opioids or general discomfort. Median duration of surgery was 32·5 min longer in the SLC group (P < 0·001). SLC was associated with a reduced incidence of vomiting on day 0 (7 versus 22 per cent; P = 0·019). The incidences of wound-related problems were comparable. One patient in the SLC group experienced a biliary leak requiring endoscopic retrograde cholangiopancreatography. The rates of incisional hernia at 12-month follow-up were 2 per cent in both groups. Cosmetic rating was significantly improved after SLC at 1 and 12 months (P < 0·001). Conclusion SLC did not significantly diminish early pain in a setting with optimized perioperative analgesic patient care. SLC may reduce postoperative vomiting. Registration number: NCT01268748 (http://www. clinicaltrials.gov).

KW - Adolescent

KW - Adult

KW - Aged

KW - Analgesics, Opioid

KW - Cholecystectomy, Laparoscopic

KW - Cholecystolithiasis

KW - Female

KW - Humans

KW - Length of Stay

KW - Middle Aged

KW - Operative Time

KW - Pain Measurement

KW - Pain, Postoperative

KW - Postoperative Nausea and Vomiting

KW - Prospective Studies

KW - Treatment Outcome

KW - Young Adult

U2 - 10.1002/bjs.9393

DO - 10.1002/bjs.9393

M3 - Journal article

C2 - 24536008

SN - 0007-1323

VL - 101

SP - 347

EP - 355

JO - British Journal of Surgery

JF - British Journal of Surgery

IS - 4

ER -