Background: Emerging attempts have been made to reduce operative trauma and improve cosmetic results of\r\nlaparoscopic cholecystectomy. There is a trend towards minimizing the number of incisions such as natural\r\ntransluminal endoscopic surgery (NOTES) and single-port laparoscopic cholecystectomy (SPLC). Many retrospective\r\ncase series propose excellent cosmesis and reduced pain in SPLC. As the latter has been confirmed in a\r\nrandomized controlled trial, patient�s satisfaction on cosmesis is still controversially debated.\r\nMethods/Design: The SPOCC trial is a prospective, multi-center, double blinded, randomized controlled study\r\ncomparing SPLC with 4-port conventional laparoscopic cholecystectomy (4PLC) in elective surgery. The hypothesis\r\nand primary objective is that patients undergoing SPLC will have a better outcome in cosmesis and body image\r\n12 weeks after surgery. This primary endpoint is assessed using a validated 8-item multiple choice type\r\nquestionnaire on cosmesis and body image. The secondary endpoint has three entities: the quality of life 12 weeks\r\nafter surgery assessed by the validated Short-Form-36 Health Survey questionnaire, postoperative pain assessed by\r\na visual analogue scale and the use of analgesics. Operative time, surgeon�s experience with SPLC and 4PLC, use of\r\nadditional ports, conversion to 4PLC or open cholecystectomy, length of stay, costs, time of work as well as intraand\r\npostoperative complications are further aspects of the secondary endpoint. Patients are randomly assigned\r\neither to SPLC or to 4PLC. Patients as well as treating physicians, nurses and assessors are blinded until the 7th\r\npostoperative day. Sample size calculation performed by estimating a difference of cosmesis of 20% (alpha = 0.05\r\nand beta = 0.90, drop out rate of 10%) resulted in a number of 55 randomized patients per arm.\r\nDiscussion: The SPOCC-trial is a prospective, multi-center, double-blind, randomized controlled study to assess\r\ncosmesis and body image after SPLC.
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