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

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ClinicalTrials.gov Identifier: NCT02485392
Recruitment Status : Unknown
Verified September 2016 by Kantonsspital Winterthur KSW.
Recruitment status was:  Active, not recruiting
First Posted : June 30, 2015
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Winterthur KSW

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 recorded safely using the SecuTrialTM program. Sample-size calculations are based on the results of the previously mentioned experimental setup by Schatte et al, utilizing an estimated effect size of 0.8, at a power of 0.8 and an alpha-error level of 0.05, as well as considering a potential additional error margin of 10-15% of the calculations (G-Power 3.1 software, Heinrich-Heine University Duesseldorf/Germany). The estimated total duration of the study is 1.5 years, including the scheduled 1-month and 1-year postoperative follow-up visits. The study will be carried out in accordance with principles enunciated in the current version of the Declaration of Helsinki, the guidelines of Good Clinical Practice (GCP) issued by International Conference on Harmonization (ICH), and Swiss regulatory authority's requirements.

Condition or disease Intervention/treatment Phase
Benign Gallbladder Disease Device: Da Vinci Single Site Robot-Assisted Cholecystectomy Device: Single Incision Laparoscopic Cholecystectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparison of Robot-assisted Single Site and Laparoscopic Single-incision Cholecystectomy for Benign Gallbladder
Study Start Date : July 2015
Actual Primary Completion Date : July 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Single-Site robot-assisted cholecystectomy
Single-Site robot-assisted cholecystectomy
Device: Da Vinci Single Site Robot-Assisted Cholecystectomy
Active Comparator: Single-incision laparoscopic cholecystectomy
Single-incision laparoscopic cholecystectomy
Device: Single Incision Laparoscopic Cholecystectomy



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

Secondary Outcome Measures :
  1. Intra-operative blood loss [ Time Frame: 1 day ]
  2. Operating time [ Time Frame: 1 day ]
  3. Intra--operative conversion rate [ Time Frame: 1 day ]
  4. Complications [ Time Frame: 1 year ]
  5. Length of hospital stay [ Time Frame: until discharge (average of 2 days) ]
  6. Costs of procedure [ Time Frame: until discharge (average of 2 days) ]
  7. Health--Related Quality of Life (HRQoL) [ Time Frame: 1 year ]
  8. Cosmesis as measured by Body Image Questionnaire (BIQ) [ Time Frame: 1 year ]
  9. Intra-operative additional trocar placement [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient compliance and geographic proximity allow proper preoperative checkup and postoperative follow-up
  • Written informed consent given by the patient
  • Women who are not breastfeeding and are not pregnant
  • Age ≥18 years
  • Symptomatic cholecystolithiasis
  • Chronic cholecystitis
  • Benign gallbladder polyps

Exclusion Criteria:

  • Significant concomitant diseases making the patient unsuitable for abdominal surgery by the judgement of the physicians involved
  • Peritoneal carcinomatosis or other extensive metastatic disease
  • American Society of Anesthesiologists (ASA) IV and V patients
  • Mental or organic disorders which could interfere with giving informed consent or receiving treatments
  • Contraindications to pneumoperitoneum
  • Suspicion of malignant disease
  • Previous extensive upper abdominal surgery
  • Acute cholecystitis
  • Emergency cholecystectomy
  • Obesity II°---III° (BMI>35.0 kg/m2)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485392


Locations
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Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Sponsors and Collaborators
Kantonsspital Winterthur KSW
Investigators
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Principal Investigator: Stefan Breitenstein, MD Kantonsspital Winterthur KSW
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT02485392    
Other Study ID Numbers: KEK-ZH 2014-0114
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases