Clinical trial NCT02485392: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Gallbladder Disease
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Surgeon's comfort as measured by LED and SMEQ questionnaires
timeFrame: 1 Day
Secondary outcomes:
measure: Intra-operative blood loss
timeFrame: 1 day
measure: Operating time
timeFrame: 1 day
measure: Intra--operative conversion rate
timeFrame: 1 day
measure: Complications
timeFrame: 1 year
measure: Length of hospital stay
timeFrame: until discharge (average of 2 days)
measure: Costs of procedure
timeFrame: until discharge (average of 2 days)
measure: Health--Related Quality of Life (HRQoL)
timeFrame: 1 year
measure: Cosmesis as measured by Body Image Questionnaire (BIQ)
timeFrame: 1 year
measure: Intra-operative additional trocar placement
timeFrame: 1 day
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
Study officials:
affiliation: Kantonsspital Winterthur KSW
name: Stefan Breitenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.