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Cosmesis and body image in patients undergoing single-port versus conventional laparoscopic cholecystectomy: a multicenter double-blinded randomized controlled trial (SPOCC-trial)


Lurje, Georg; Raptis, Dimitri Aristotle; Steinemann, Daniel Christian; Amygdalos, Iakovos; Kambakamba, Patryk; Petrowsky, Henrik; Lesurtel, Mickaël; Zehnder, Adrian; Wyss, Roland; Clavien, Pierre-Alain; Breitenstein, Stefan (2015). Cosmesis and body image in patients undergoing single-port versus conventional laparoscopic cholecystectomy: a multicenter double-blinded randomized controlled trial (SPOCC-trial). Annals of Surgery, 262(5):728-735.

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.

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.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Visceral and Transplantation Surgery
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:November 2015
Deposited On:26 Jan 2016 11:53
Last Modified:01 Dec 2016 01:02
Publisher:Lippincott Williams & Wilkins
ISSN:0003-4932
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1097/SLA.0000000000001474
PubMed ID:26583659

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