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Randomized Controlled Trial Multicenter Study
Cosmesis and Body Image in Patients Undergoing Single-port Versus Conventional Laparoscopic Cholecystectomy: A Multicenter Double-blinded Randomized Controlled Trial (SPOCC-trial).
- Georg Lurje, Dimitri Aristotle Raptis, Daniel Christian Steinemann, Iakovos Amygdalos, Patryk Kambakamba, Henrik Petrowsky, Mickaël Lesurtel, Adrian Zehnder, Roland Wyss, Pierre-Alain Clavien, and Stefan Breitenstein.
- *Department of Surgery, University Hospital Zurich, Zurich, Switzerland †Department of Surgery, University Hospital RWTH Aachen, Aachen, Germany ‡Department of Surgery, Cantonal Hospital Winterthur, Winterthur, Switzerland.
- Ann. Surg. 2015 Nov 1;262(5):728-34; discussion 734-5.
ObjectiveTo evaluate cosmesis, body image, pain, and quality of life (QoL) after single-port laparoscopic cholecystectomy (SPLC) versus conventional 4-port laparoscopic cholecystectomy (4PLC).BackgroundThe impact of SPLC on improving cosmesis, body image, pain, and QoL has not been evaluated in double-blinded randomized controlled trials (RCT). This approach therefore remains controversial.MethodsBetween October 2011 and February 2014, 110 patients from 2 centers were randomly assigned to SPLC (n = 55) or 4PLC (n = 55). Primary endpoints were a validated cosmesis (3-24 points) and body image (5-20 points) score after 3 and 12 months. Secondary endpoints included operative duration, postoperative pain, complications, QoL, and length of hospital stay. Patients, physicians, and nurses were blinded until the seventh postoperative day.ResultsDemographics were equally distributed between both groups (mean age: 46 years, SD: 14, 62 females, 34 males). The SPLC-group showed superior mean cosmesis and body image compared with the 4PLC-group at 12-weeks (21 vs 16, P < 0.001 and 5 vs 6, P = 0.013, respectively) and at 1-year (24 vs 16, P < 0.001 and 5 vs 6, P < 0.017, respectively). Operation duration was longer in the SPLC-group (mean 101 vs 90 minutes, p = 0.031). Although postoperative pain was less in the SPLC-group (mean VAS 1 vs 2, p = 0.005), there were no differences in complications, and length of hospital-stay.ConclusionsThis is the first multicenter double-blinded RCT reporting superior short- and long-term cosmetic and body image, postoperative pain, and QoL in SPLC compared with 4PLC. Although cost-effectiveness is still a subject of ongoing debate, SPLC should be offered to patients undergoing surgery for benign gallbladder disease.
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