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

Abstract

BackgroundEmerging 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/DesignThe 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.DiscussionThe 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

Comparison of Cosmetic Outcome Between Single-Incision Laparoscopic Cholecystectomy and Conventional Laparoscopic Cholecystectomy in Rural Indian Population: A Randomized Clinical Trial

“…The body image scale measures patients' perception and satisfaction with their bodies after surgery, and it is calculated by reverse scoring and summing the responses to questions 1 through 5; it ranges from 5 to 20 with a higher number representing greater body image perception. The cosmetic scale assesses satisfaction with surgical scars and is calculated by simply summing responses to questions 6-8, for a score range of 3-24, with a higher score indicating greater cosmetic satisfaction [15][16][17].…”

Patient perception, satisfaction and cosmetic results of surgical atrial septal defect closure: Minithoracotomy versus sternotomy

“…In this evaluative tool, a psychologist asked the parents of our patients the questions related to body image, and the patients answered the cosmetic subscale questions. The BIQ is a Likert-type instrument [8,9] that assesses body-image satisfaction/dissatisfaction by measuring the degree of discrepancy of 11 self-perceived and idealized physical attributes (e.g., weight, facial features, muscle tone/ definition, physical strength, overall appearance, etc. ).…”

Transumbilical single-incision laparoscopic cholecystectomy: long-term review from a single center

“…The theoretical advantage of SILC is better in cosmesis [13] with equally fast recovery and light intra-abdominal adhesion [14], comparing with traditional multiport laparoscopic cholecystectomy (TMLC), but no gain of postoperative pain and complications [13,15]. It is also convenient to convert to TMLC when needed [16].…”