- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02485392
A Comparison of Robot-assisted Single Site and Laparoscopic Single-incision Cholecystectomy for Benign Gallbladder
September 8, 2016 updated by: Kantonsspital Winterthur KSW
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Winterthur, Switzerland, 8401
- Kantonsspital Winterthur
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Single-Site robot-assisted cholecystectomy
|
|
Active Comparator: Single-incision laparoscopic cholecystectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Surgeon's comfort as measured by LED and SMEQ questionnaires
Time Frame: 1 Day
|
1 Day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complications
Time Frame: 1 year
|
1 year
|
Intra-operative blood loss
Time Frame: 1 day
|
1 day
|
Operating time
Time Frame: 1 day
|
1 day
|
Intra--operative conversion rate
Time Frame: 1 day
|
1 day
|
Length of hospital stay
Time Frame: until discharge (average of 2 days)
|
until discharge (average of 2 days)
|
Costs of procedure
Time Frame: until discharge (average of 2 days)
|
until discharge (average of 2 days)
|
Health--Related Quality of Life (HRQoL)
Time Frame: 1 year
|
1 year
|
Cosmesis as measured by Body Image Questionnaire (BIQ)
Time Frame: 1 year
|
1 year
|
Intra-operative additional trocar placement
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stefan Breitenstein, MD, Kantonsspital Winterthur KSW
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Grochola LF, Soll C, Zehnder A, Wyss R, Herzog P, Breitenstein S. Robot-assisted versus laparoscopic single-incision cholecystectomy: results of a randomized controlled trial. Surg Endosc. 2019 May;33(5):1482-1490. doi: 10.1007/s00464-018-6430-7. Epub 2018 Sep 14.
- Grochola LF, Soll C, Zehnder A, Wyss R, Herzog P, Breitenstein S. Robot-assisted single-site compared with laparoscopic single-incision cholecystectomy for benign gallbladder disease: protocol for a randomized controlled trial. BMC Surg. 2017 Feb 9;17(1):13. doi: 10.1186/s12893-017-0206-1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
July 1, 2016
Study Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
February 19, 2015
First Submitted That Met QC Criteria
June 25, 2015
First Posted (Estimate)
June 30, 2015
Study Record Updates
Last Update Posted (Estimate)
September 9, 2016
Last Update Submitted That Met QC Criteria
September 8, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH 2014-0114
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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