A Comparison of Robot-assisted Single Site and Laparoscopic Single-incision Cholecystectomy for Benign Gallbladder
Primary Purpose
Benign Gallbladder Disease
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Da Vinci Single Site Robot-Assisted Cholecystectomy
Single Incision Laparoscopic Cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Benign Gallbladder Disease
Eligibility 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)
Sites / Locations
- Kantonsspital Winterthur
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single-Site robot-assisted cholecystectomy
Single-incision laparoscopic cholecystectomy
Arm Description
Single-Site robot-assisted cholecystectomy
Single-incision laparoscopic cholecystectomy
Outcomes
Primary Outcome Measures
Surgeon's comfort as measured by LED and SMEQ questionnaires
Secondary Outcome Measures
Intra-operative blood loss
Operating time
Intra--operative conversion rate
Complications
Length of hospital stay
Costs of procedure
Health--Related Quality of Life (HRQoL)
Cosmesis as measured by Body Image Questionnaire (BIQ)
Intra-operative additional trocar placement
Full Information
NCT ID
NCT02485392
First Posted
February 19, 2015
Last Updated
September 8, 2016
Sponsor
Kantonsspital Winterthur KSW
1. Study Identification
Unique Protocol Identification Number
NCT02485392
Brief Title
A Comparison of Robot-assisted Single Site and Laparoscopic Single-incision Cholecystectomy for Benign Gallbladder
Official Title
A Comparison of Robot-assisted Single Site and Laparoscopic Single-incision Cholecystectomy for Benign Gallbladder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kantonsspital Winterthur KSW
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Gallbladder Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-Site robot-assisted cholecystectomy
Arm Type
Active Comparator
Arm Description
Single-Site robot-assisted cholecystectomy
Arm Title
Single-incision laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
Single-incision laparoscopic cholecystectomy
Intervention Type
Device
Intervention Name(s)
Da Vinci Single Site Robot-Assisted Cholecystectomy
Intervention Type
Device
Intervention Name(s)
Single Incision Laparoscopic Cholecystectomy
Primary Outcome Measure Information:
Title
Surgeon's comfort as measured by LED and SMEQ questionnaires
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Intra-operative blood loss
Time Frame
1 day
Title
Operating time
Time Frame
1 day
Title
Intra--operative conversion rate
Time Frame
1 day
Title
Complications
Time Frame
1 year
Title
Length of hospital stay
Time Frame
until discharge (average of 2 days)
Title
Costs of procedure
Time Frame
until discharge (average of 2 days)
Title
Health--Related Quality of Life (HRQoL)
Time Frame
1 year
Title
Cosmesis as measured by Body Image Questionnaire (BIQ)
Time Frame
1 year
Title
Intra-operative additional trocar placement
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Breitenstein, MD
Organizational Affiliation
Kantonsspital Winterthur KSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
30218263
Citation
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.
Results Reference
derived
PubMed Identifier
28183345
Citation
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.
Results Reference
derived
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A Comparison of Robot-assisted Single Site and Laparoscopic Single-incision Cholecystectomy for Benign Gallbladder
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