NCT01709877

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

July 1, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

October 17, 2012

Last Update Submit

June 28, 2013

Conditions

Gallstones

Keywords

Multiport laparoscopySingle Port LaparoscopySymptomatic Gallstones

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Postoperative course

    1 week

  • Duration of hospital stay

    6 days

  • Return of bowel function

    12, 24, 48 hours

Study Arms (2)

Traditional multiport laparoscopic cholecystectomy

ACTIVE COMPARATOR

Standard laparoscopic cholecystectomy performed by the traditional multiport technique

Procedure: Cholecystectomy

Single port laparoscopic cholecystectomy

EXPERIMENTAL

Laparoscopic cholecystectomy performed using the reusable ENDOCONE system with dedicated curved coaxial instruments

Procedure: Cholecystectomy

Interventions

CholecystectomyPROCEDURE

Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease

Single port laparoscopic cholecystectomyTraditional multiport laparoscopic cholecystectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic gallstone disease
  • ASA I/II
  • Age between 18 and 80 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ospedale San Donato

Arezzo, AR, Italy

NOT YET RECRUITING

Ospedale Campo di Marte

Lucca, LU, Italy

NOT YET RECRUITING

Ospedinale di Cisanello

Pisa, PI, 56100, Italy

RECRUITING

Ospedale Felice Lotti

Pontedera, PI, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Gallstones

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Franco Mosca, Prof, MD

    AOUP

    PRINCIPAL INVESTIGATOR

  • Alfred Cuschieri, Prof, MD

    Scuola Superiore Sant'Anna di Pisa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Franco Mosca, Prof. MD

CONTACT

+39 (0)50 996820f.mosca@med.unipi.it

Giovanni Caprili, MD

CONTACT

+39 3286875111mabcap@libero.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 18, 2012

Study Start

April 1, 2013

Primary Completion

July 1, 2014

Study Completion

November 1, 2014

Last Updated

July 1, 2013

Record last verified: 2013-06

Locations

IT(4)