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

Not Applicable

• Conditions: Benign Gallbladder Disease
• Interventions: Device: Single Incision Laparoscopic Cholecystectomy; Device: Da Vinci Single Site Robot-Assisted Cholecystectomy

• Registration Number: NCT02485392
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-30
• Study Start: 2015-07
• Primary Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-incision laparoscopic cholecystectomy	Single Incision Laparoscopic Cholecystectomy	Single-incision laparoscopic cholecystectomy
Single-Site robot-assisted cholecystectomy	Da Vinci Single Site Robot-Assisted Cholecystectomy	Single-Site robot-assisted cholecystectomy

Primary Outcome Measures

Name	Time	Method
Surgeon's comfort as measured by LED and SMEQ questionnaires	1 Day

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland