EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

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

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.

Study Overview

• Status: Unknown
• Conditions: Gallstones
• Intervention / Treatment: Procedure: Cholecystectomy

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Franco Mosca, Prof. MD; Phone Number: +39 (0)50 996820; Email: f.mosca@med.unipi.it
• Study Contact Backup: Name: Giovanni Caprili, MD; Phone Number: +39 3286875111; Email: mabcap@libero.it

Study Locations

• Italy
  • AR
    • Arezzo, AR, Italy
      • Not yet recruiting
      • Ospedale San Donato
      • Contact: Fabio Sbrana, MD
  • LU
    • Lucca, LU, Italy
      • Not yet recruiting
      • Ospedale Campo di Marte
      • Contact: Andrea Carobbi, MD
  • PI
    • Pisa, PI, Italy, 56100
      • Recruiting
      • Ospedinale di Cisanello
      • Contact: Luca Morelli, MD; Phone Number: +39 (0)50 996820; Email: llmorelli74@hotmail.com
    • Pontedera, PI, Italy
      • Not yet recruiting
      • Ospedale Felice Lotti
      • Contact: Orlando Goletti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Traditional multiport laparoscopic cholecystectomy; Standard laparoscopic cholecystectomy performed by the traditional multiport technique	Procedure: Cholecystectomy; Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease
EXPERIMENTAL: Single port laparoscopic cholecystectomy; Laparoscopic cholecystectomy performed using the reusable ENDOCONE system with dedicated curved coaxial instruments	Procedure: Cholecystectomy; Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		30 days
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

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero, Universitaria Pisana
• Collaborators: Scuola Superiore Sant'Anna di Pisa; Regione Toscana; Università di Pisa
• Investigators: Principal Investigator: Franco Mosca, Prof, MD, AOUP; Principal Investigator: Alfred Cuschieri, Prof, MD, Scuola Superiore Sant'Anna di Pisa

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ANTICIPATED): July 1, 2014
• Study Completion (ANTICIPATED): November 1, 2014

Study Registration Dates

• First Submitted: October 17, 2012
• First Submitted That Met QC Criteria: October 17, 2012
• First Posted (ESTIMATE): October 18, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 1, 2013
• Last Update Submitted That Met QC Criteria: June 28, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Multiport laparoscopy; Single Port Laparoscopy; Symptomatic Gallstones
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: AOUP_1; RF-2009-1535329 (OTHER: Ministero della Salute - Direzione Generale della Ricerca Scientifica e Tecnologica; Regione Toscana)