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).
RCT Entities:
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).
Authors: Ryan C Broderick; Pablo Omelanczuk; Cristina R Harnsberger; Hans F Fuchs; Martin Berducci; Jorge Nefa; Javier Nicolia; Moneer Almadani; Garth R Jacobsen; Bryan J Sandler; Santiago Horgan Journal: Surg Endosc Date: 2014-08-23 Impact factor: 4.584
Authors: Stavros A Antoniou; Josep M García-Alamino; Shahab Hajibandeh; Shahin Hajibandeh; Michael Weitzendorfer; Filip E Muysoms; Frank A Granderath; George E Chalkiadakis; Klaus Emmanuel; George A Antoniou; Meropi Gioumidou; Styliani Iliopoulou-Kosmadaki; Maria Mathioudaki; Kyriakos Souliotis Journal: Surg Endosc Date: 2017-07-19 Impact factor: 4.584
Authors: A Balaphas; N C Buchs; S P Naiken; M E Hagen; A Zawodnik; M K Jung; G Varnay; L H Bühler; P Morel Journal: Hernia Date: 2017-05-09 Impact factor: 4.739