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Randomized Controlled Trial
, 262 (5), 728-34; discussion 734-5

Cosmesis and Body Image in Patients Undergoing Single-port Versus Conventional Laparoscopic Cholecystectomy: A Multicenter Double-blinded Randomized Controlled Trial (SPOCC-trial)

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Randomized Controlled Trial

Cosmesis and Body Image in Patients Undergoing Single-port Versus Conventional Laparoscopic Cholecystectomy: A Multicenter Double-blinded Randomized Controlled Trial (SPOCC-trial)

Georg Lurje et al. Ann Surg.

Abstract

Objective: To evaluate cosmesis, body image, pain, and quality of life (QoL) after single-port laparoscopic cholecystectomy (SPLC) versus conventional 4-port laparoscopic cholecystectomy (4PLC).

Background: The 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.

Methods: Between 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.

Results: Demographics 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.

Conclusions: This 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.

Trial registration: ClinicalTrials.gov NCT01278472.

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