BACKGROUND: We report a prospective randomised comparison between laparoscopic and small-incision cholecystectomy in 200 patients which was designed to eliminate bias for or against either technique. METHODS: Patients were randomised in the operating theatre and anaesthetic technique and pain-control methods were standardised. Four experienced surgeons did both types of procedure. Identical wound dressings were applied in both groups so that carers could be kept blind to the type of operation. FINDINGS: There was no significant difference between the groups for age, sex, body mass index, and American Society of Anaesthesiologists grade. Laparoscopic cholecystectomy took significantly longer than small-incision cholecystectomy (median 65 [range 27-140] min vs 40 [18-142] min, p<0.001). The operating time included operative cholangiography which was attempted in all patients. We found no significant difference between the groups for hospital stay (postoperative nights in hospital, median 3-0 [1-17] nights for laparoscopic vs 3-0 [1-14] nights for small-incision, p=0.74), time back to work for employed persons (median 5-0 weeks vs 4.0 weeks; p=0.39), and time to full activity (median 3-0 weeks vs 3.0 weeks; p=0.15). INTERPRETATION:Laparoscopic cholecystectomy takes longer to do than small-incision cholecystectomy and does not have any significant advantages in terms of hospital stay or postoperative recovery.
RCT Entities:
BACKGROUND: We report a prospective randomised comparison between laparoscopic and small-incision cholecystectomy in 200 patients which was designed to eliminate bias for or against either technique. METHODS:Patients were randomised in the operating theatre and anaesthetic technique and pain-control methods were standardised. Four experienced surgeons did both types of procedure. Identical wound dressings were applied in both groups so that carers could be kept blind to the type of operation. FINDINGS: There was no significant difference between the groups for age, sex, body mass index, and American Society of Anaesthesiologists grade. Laparoscopic cholecystectomy took significantly longer than small-incision cholecystectomy (median 65 [range 27-140] min vs 40 [18-142] min, p<0.001). The operating time included operative cholangiography which was attempted in all patients. We found no significant difference between the groups for hospital stay (postoperative nights in hospital, median 3-0 [1-17] nights for laparoscopic vs 3-0 [1-14] nights for small-incision, p=0.74), time back to work for employed persons (median 5-0 weeks vs 4.0 weeks; p=0.39), and time to full activity (median 3-0 weeks vs 3.0 weeks; p=0.15). INTERPRETATION: Laparoscopic cholecystectomy takes longer to do than small-incision cholecystectomy and does not have any significant advantages in terms of hospital stay or postoperative recovery.
Authors: Hanns-Peter Knaebel; Markus K Diener; Moritz N Wente; Hartwig Bauer; Markus W Büchler; Matthias Rothmund; Christoph M Seiler Journal: Langenbecks Arch Surg Date: 2005-02-22 Impact factor: 3.445