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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01709877

Enrollment

300

Registered

2012-10-18

Start date

2013-04-30

Completion date

2014-11-30

Last updated

2013-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gallstones

Keywords

Multiport laparoscopy, Single Port Laparoscopy, Symptomatic Gallstones

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.

Interventions

PROCEDURECholecystectomy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Contacts

Primary ContactFranco Mosca, Prof. MD

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

Backup ContactGiovanni Caprili, MD

mabcap@libero.it+39 3286875111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026