Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2011 Sep 12;11:24.
doi: 10.1186/1471-2482-11-24.

Cosmesis and Body Image After Single-Port Laparoscopic or Conventional Laparoscopic Cholecystectomy: A Multicenter Double Blinded Randomised Controlled Trial (SPOCC-trial)

Affiliations
Free PMC article
Randomized Controlled Trial

Cosmesis and Body Image After Single-Port Laparoscopic or Conventional Laparoscopic Cholecystectomy: A Multicenter Double Blinded Randomised Controlled Trial (SPOCC-trial)

Daniel C Steinemann et al. BMC Surg. .
Free PMC article

Abstract

Background: Emerging attempts have been made to reduce operative trauma and improve cosmetic results of laparoscopic cholecystectomy. There is a trend towards minimizing the number of incisions such as natural transluminal endoscopic surgery (NOTES) and single-port laparoscopic cholecystectomy (SPLC). Many retrospective case series propose excellent cosmesis and reduced pain in SPLC. As the latter has been confirmed in a randomized controlled trial, patient's satisfaction on cosmesis is still controversially debated.

Methods/design: The SPOCC trial is a prospective, multi-center, double blinded, randomized controlled study comparing SPLC with 4-port conventional laparoscopic cholecystectomy (4PLC) in elective surgery. The hypothesis and primary objective is that patients undergoing SPLC will have a better outcome in cosmesis and body image 12 weeks after surgery. This primary endpoint is assessed using a validated 8-item multiple choice type questionnaire on cosmesis and body image. The secondary endpoint has three entities: the quality of life 12 weeks after surgery assessed by the validated Short-Form-36 Health Survey questionnaire, postoperative pain assessed by a visual analogue scale and the use of analgesics. Operative time, surgeon's experience with SPLC and 4PLC, use of additional ports, conversion to 4PLC or open cholecystectomy, length of stay, costs, time of work as well as intra- and postoperative complications are further aspects of the secondary endpoint. Patients are randomly assigned either to SPLC or to 4PLC. Patients as well as treating physicians, nurses and assessors are blinded until the 7th postoperative day. Sample size calculation performed by estimating a difference of cosmesis of 20% (alpha = 0.05 and beta = 0.90, drop out rate of 10%) resulted in a number of 55 randomized patients per arm.

Discussion: The SPOCC-trial is a prospective, multi-center, double-blind, randomized controlled study to assess cosmesis and body image after SPLC.

Trial registration: (clinicaltrial.gov): NCT 01278472.

Trial registration: ClinicalTrials.gov NCT00904865 NCT01094379 NCT01104727 NCT01339325 NCT01348620.

Figures

Figure 1
Figure 1
Study flowchart.
Figure 2
Figure 2
Setting in Single-Port laparoscopic cholecystectomy.
Figure 3
Figure 3
Setting in 4-Port laparoscopic cholecystectomy.

Similar articles

See all similar articles

Cited by 15 articles

See all "Cited by" articles

References

    1. Litynski GS. Erich Muhe and the rejection of laparoscopic cholecystectomy (1985): a surgeon ahead of his time. JSLS. 1998;2(4):341–346. - PMC - PubMed
    1. Begos DG, Modlin IM. Laparoscopic cholecystectomy: from gimmick to gold standard. J Clin Gastroenterol. 1994;19(4):325–330. doi: 10.1097/00004836-199412000-00015. - DOI - PubMed
    1. Scott DJ, Tang SJ, Fernandez R, Bergs R, Goova MT, Zeltser I, Kehdy FJ, Cadeddu JA. Completely transvaginal NOTES cholecystectomy using magnetically anchored instruments. Surg Endosc. 2007;21(12):2308–2316. doi: 10.1007/s00464-007-9498-z. - DOI - PubMed
    1. Pearl JP, Ponsky JL. Natural orifice translumenal endoscopic surgery: a critical review. J Gastrointest Surg. 2008;12(7):1293–1300. doi: 10.1007/s11605-007-0424-4. - DOI - PubMed
    1. Rao PP, Bhagwat SM, Rane A. The feasibility of single port laparoscopic cholecystectomy: a pilot study of 20 cases. HPB (Oxford) 2008;10(5):336–340. - PMC - PubMed

Publication types

Associated data

Feedback