EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

Study Overview
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Brief Summary
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Its main objective is to evaluate the clinical outcome (including patient reported outcomes) and health economic assessment (HTA) of a new re-usable system for Single Port Laparoscopic Surgery - ENDOCONE SYSTEM developed by Prof Cuschieri by undertaking a randomised controlled prospective clinical trial (RCT) on specific operations performed (on a random allocation basis) by either the traditional multi-port laparoscopic approach or the Single Port- ENDOCONE system by Karl Storz. To this effect, 300 patients meeting the trial inclusion criteria will be randomised over a three year period to have the operation by either of the two approaches.

Official Title
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Randomised Non-inferiority Trial of Laparoscopic Cholecystectomy Performed With EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach Using Clinical, PROMS and Health Economic Endpoints

Conditions
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Gallstones

Intervention / Treatment
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* Procedure: Cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic gallstone disease ASA I/II Age between 18 and 80 years Exclusion Criteria: ASA III or more significant co-morbid cardiovascular, neurological diseases, diabetics and chronic obstructive airway disease patients with previous history of invasive cancer patients with previous surgery patients requiring urgent/emergency interventions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional multiport laparoscopic cholecystectomy<br>Standard laparoscopic cholecystectomy performed by the traditional multiport technique | Procedure: Cholecystectomy<br>* Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease<br>|
| Experimental: Single port laparoscopic cholecystectomy<br>Laparoscopic cholecystectomy performed using the reusable ENDOCONE system with dedicated curved coaxial instruments | Procedure: Cholecystectomy<br>* Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion rate | 1 = if the intervention is converted to open surgery 0 = if the intervention is completed using standard laparoscopy or single port | During the intervention | 
| Morbidity | 1 = if the patient has surgical complications 0 = no complications | 30 days | 
| Mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative course | pain, measured using 1) visual linear analogue scale and 2) analgesic administration | 1 week | 
| Duration of hospital stay | Date of the operation Date of hospital discharge | 6 days | 
| Return of bowel function | Passage of flatus and/or bowel motion | 12, 24, 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiport laparoscopy, Single Port Laparoscopy, Symptomatic Gallstones