Clinical Trial: A Comparison of Robot-assisted Single Site and Laparoscopic Single-incision Cholecystectomy for Benign Gallbladder

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Comparison of Robot-assisted Single Site and Laparoscopic Single-incision Cholecystectomy for Benign Gallbladder

Brief Summary: A single-blinded randomized clinical trial (RCT) designed to compare Single-Site robot-assisted with single-incision laparoscopic cholecystectomy. The study directly compares both surgical approaches in a cohort of 60 patients (30 patients in each arm) with benign gallbladder disease from the Department of Surgery at the Cantonal Hospital of Winterthur (Kantonsspital Winterthur) in Switzerland. The primary endpoint of the study is the surgeon's physical and mental stress load at the time of surgery and is assessed by validated Local Experienced Discomfort (LED) and Subjective Mental Effort Questionnaire (SMEQ) visual analogue scales. The secondary endpoints include costs of the procedure, intra-operative blood loss, operating time, intra-operative conversion rate and additional trocar placement, complications, length of hospital stay, Health-Related Quality of Life (HRQoL) and cosmesis. HRQoL and cosmesis will be assessed using the validated Gastrointestinal Quality of Life Index (GIQLI) and the Body Image Questionnaires (BIQ), respectively. The inclusion criteria cover most notably symptomatic cholecystolithiasis, chronic cholecystitis, benign gallbladder polyps and age ≥18 years. The exclusion criteria are, among others, acute cholecystitis, emergency cholecystectomy, previous extensive upper abdominal surgery and suspicion of malignant disease. Non-stratified block randomization (random block sizes 2 and 4) will be used to achieve balance in the allocation of participants to both treatments arms and prevent a premature decoding of the randomization scheme. Hereby, the patient will not be informed about the group assignment until the last outpatient follow-up and only after he/she has completed and returned all required questionnaires (GIQLI and BIQ). The operation will be performed according to the group assignment by senior surgeons only who have a wide experience in both robotic Single-Site and conventional single-incision laparoscopy. All data are record

Detailed Summary:
Sponsor: Kantonsspital Winterthur KSW

Current Primary Outcome: Surgeon's comfort as measured by LED and SMEQ questionnaires [ Time Frame: 1 Day ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Intra-operative blood loss [ Time Frame: 1 day ]
  • Operating time [ Time Frame: 1 day ]
  • Intra--operative conversion rate [ Time Frame: 1 day ]
  • Complications [ Time Frame: 1 year ]
  • Length of hospital stay [ Time Frame: until discharge (average of 2 days) ]
  • Costs of procedure [ Time Frame: until discharge (average of 2 days) ]
  • Health--Related Quality of Life (HRQoL) [ Time Frame: 1 year ]
  • Cosmesis as measured by Body Image Questionnaire (BIQ) [ Time Frame: 1 year ]
  • Intra-operative additional trocar placement [ Time Frame: 1 day ]


Original Secondary Outcome:

  • Intra-operative blood loss [ Time Frame: 1 day ]
  • Operating time [ Time Frame: 1 day ]
  • Intra--operative conversion rate [ Time Frame: 1 day ]
  • Complications [ Time Frame: 1 year ]
  • Length of hospital stay [ Time Frame: until discharge (average of 2 days) ]
  • Costs of procedure [ Time Frame: until discharge (average of 2 days) ]
  • Health--Related Quality of Life (HRQoL) [ Time Frame: 1 year ]
  • Cosmesis [ Time Frame: 1 year ]
  • Intra-operative additional trocar placement [ Time Frame: 1 day ]


Information By: Kantonsspital Winterthur KSW

Dates:
Date Received: February 19, 2015
Date Started: July 2015
Date Completion: July 2017
Last Updated: September 8, 2016
Last Verified: September 2016