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

Benign Gallbladder Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02485392
• Other study ID #: KEK-ZH 2014-0114
• Status: Active, not recruiting
• Phase: N/A
• First received: February 19, 2015
• Last updated: September 8, 2016
• Start date: July 2015
• Est. completion date: July 2017

Study information

• Verified date: September 2016
• Source: Kantonsspital Winterthur KSW
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kantonale Ethikkommission Kanton Zurich: Switzerland
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Gallbladder Disease
• Gallbladder Diseases

Intervention

Device:
• Da Vinci Single Site Robot-Assisted Cholecystectomy

• Single Incision Laparoscopic Cholecystectomy

Locations

Country	Name	City	State
Switzerland	Kantonsspital Winterthur	Winterthur

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgeon's comfort as measured by LED and SMEQ questionnaires		1 Day	No
Secondary	Intra-operative blood loss		1 day	Yes
Secondary	Operating time		1 day	No
Secondary	Intra--operative conversion rate		1 day	No
Secondary	Complications		1 year	Yes
Secondary	Length of hospital stay		until discharge (average of 2 days)	No
Secondary	Costs of procedure		until discharge (average of 2 days)	No
Secondary	Health--Related Quality of Life (HRQoL)		1 year	No
Secondary	Cosmesis as measured by Body Image Questionnaire (BIQ)		1 year	No
Secondary	Intra-operative additional trocar placement		1 day	No