Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy
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Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy. / Jørgensen, Lars Nannestad; Rosenberg, J; Al-Tayar, H; Assaadzadeh, S; Helgstrand, F; Bisgaard, T.
In: British Journal of Surgery, Vol. 101, No. 4, 03.2014, p. 347-355.Research output: Contribution to journal › Journal article › Research › peer-review
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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
VL - 101
SP - 347
EP - 355
JO - British Journal of Surgery
JF - British Journal of Surgery
SN - 0007-1323
IS - 4
ER -
ID: 137630738