Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial)

Daniel C Steinemann, Dimitri A Raptis, Georg Lurje, Christian E Oberkofler, Roland Wyss, Adrian Zehnder, Mickael Lesurtel, René Vonlanthen, Pierre-Alain Clavien, Stefan Breitenstein, Daniel C Steinemann, Dimitri A Raptis, Georg Lurje, Christian E Oberkofler, Roland Wyss, Adrian Zehnder, Mickael Lesurtel, René Vonlanthen, Pierre-Alain Clavien, Stefan Breitenstein

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 NCT00904865 NCT01278472 NCT01348620 NCT01094379 NCT01104727 NCT01339325.

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.

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.
    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.
    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.
    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.
    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.
    1. Schlager A, Khalaileh A, Shussman N, Elazary R, Keidar A, Pikarsky AJ, Ben-Shushan A, Shibolet O, Horgan S, Talamini M, Zamir G, Rivkind AI, Mintz Y. Providing more through less: current methods of retraction in SIMIS and NOTES cholecystectomy. Surg Endosc. 2010;24(7):1542–1546. doi: 10.1007/s00464-009-0807-6.
    1. Ma J, Cassera MA, Spaun GO, Hammill CW, Hansen PD, Aliabadi-Wahle S. Randomized Controlled Trial Comparing Single-Port Laparoscopic Cholecystectomy and 4-Port Laparoscopic Cholecystectomy. Ann Surg. 2011.
    1. Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. pp. 1842–1848.
    1. Allemann P, Schafer M, Demartines N. Critical appraisal of single port access cholecystectomy. Br J Surg. 2010;97(10):1476–1480. doi: 10.1002/bjs.7189.
    1. Antoniou SA, Pointner R, Granderath FA. Single-incision laparoscopic cholecystectomy: a systematic review. Surg Endosc. 2011;25(2):367–377. doi: 10.1007/s00464-010-1217-5.
    1. Giger U, Ouaissi M, Schmitz SF, Krahenbuhl S, Krahenbuhl L. Bile duct injury and use of cholangiography during laparoscopic cholecystectomy. Br J Surg. 2011;98(3):391–396. doi: 10.1002/bjs.7335.
    1. Tacchino R, Greco F, Matera D. Single-incision laparoscopic cholecystectomy: surgery without a visible scar. Surg Endosc. 2009;23(4):896–899. doi: 10.1007/s00464-008-0147-y.
    1. Chow A, Purkayastha S, Aziz O, Paraskeva P. Single-incision laparoscopic surgery for cholecystectomy: an evolving technique. Surg Endosc. 2010;24(3):709–714. doi: 10.1007/s00464-009-0655-4.
    1. Bignell M, Hindmarsh A, Nageswaran H, Mothe B, Jenkinson A, Mahon D, Rhodes M. Assessment of cosmetic outcome after laparoscopic cholecystectomy among women 4 years after laparoscopic cholecystectomy: is there a problem? Surg Endosc. 2011.
    1. Dunker MS, Stiggelbout AM, van Hogezand RA, Ringers J, Griffioen G, Bemelman WA. Cosmesis and body image after laparoscopic-assisted and open ileocolic resection for Crohn's disease. Surg Endosc. 1998;12(11):1334–1340. doi: 10.1007/s004649900851.
    1. Lind MY, Hop WC, Weimar W, JN IJ. Body image after laparoscopic or open donor nephrectomy. Surg Endosc. 2004;18(8):1276–1279. doi: 10.1007/s00464-003-9113-x.
    1. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30(6):473–483. doi: 10.1097/00005650-199206000-00002.
    1. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205–213. doi: 10.1097/.
    1. Keus F, de Vries J, Gooszen HG, van Laarhoven CJ. Laparoscopic versus small-incision cholecystectomy: health status in a blind randomised trial. Surg Endosc. 2008;22(7):1649–1659. doi: 10.1007/s00464-007-9675-0.
    1. Lurie I, Levine SZ. Meta-analysis of dropout rates in SSRIs versus placebo in randomized clinical trials of PTSD. J Nerv Ment Dis. pp. 116–124.
    1. Ergina PL, Cook JA, Blazeby JM, Boutron I, Clavien PA, Reeves BC, Seiler CM, Altman DG, Aronson JK, Barkun JS, Campbell WB, Feldman LS, Flum DR, Glasziou P, Maddern GJ, Marshall JC, McCulloch P, Nicholl J, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Grant A. et al.Challenges in evaluating surgical innovation. Lancet. 2009;374(9695):1097–1104. doi: 10.1016/S0140-6736(09)61086-2.
    1. Steinemann DC, Clavien PA, Breitenstein S. Single-Port cholecystectomy using internal retraction. swissknife. 2011.
    1. Volzke H, Robinson DM, John U. Association between thyroid function and gallstone disease. World J Gastroenterol. 2005;11(35):5530–5534.
    1. Asakuma M, Hayashi M, Komeda K, Shimizu T, Hirokawa F, Miyamoto Y, Okuda J, Tanigawa N. Impact of single-port cholecystectomy on postoperative pain. Br J Surg. 2011;98(7):991–995. doi: 10.1002/bjs.7486.

Source: PubMed

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