Condition category
Cancer
Date applied
30/03/2020
Date assigned
07/04/2020
Last edited
06/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A hemicolectomy is a surgical procedure that involves removing a segment of the colon, for example to treat colon cancer. The aim of this study is to compare the short-term outcomes of patients who undergo laparoscopic (keyhole surgery) right hemicolectomy using the CME and CVL technique (CME group) with patients who undergo conventional right-sided colonic resection (Not Complete Mesocolic Excision, NCME group).

Who can participate?
Patients with right-sided colon cancer who are undergoing laparoscopic colonic resection (removal of the part of the colon containing the cancer)

What does the study involve?
Participants are randomly allocated to undergo laparoscopic complete mesocolic excision with central vascular ligation (CME group) or laparoscopic standard right hemicolectomy (Not Complete Mesocolic Excision, NCME group). Both groups are followed up during their hospital stay or 30 days and long term to obtain results about ontological (cancer) outcomes.

What are the possible benefits and risks of participating?
Possible benefits include better surgical outcomes in the CME group. Possible risks include a higher rate of complications in the CME group than the NCME group.

Where is the study run from?
1. University Hospital Policlinico "P. Giaccone" of Palermo (Italy)
2. University of Palermo (Italy)

When is the study starting and how long is it expected to run for?
October 2014 to December 2022

Who is funding the study?
University of Palermo (Italy)

Who is the main contact?
1. Prof. Agrusa Antonino
2. Dr Giuseppe Di Buono
giuseppe.dibuono@unipa.it

Trial website

Contact information

Type

Scientific

Primary contact

Dr Giuseppe Di Buono

ORCID ID

http://orcid.org/0000-0001-9928-6448

Contact details

Via L. giuffrè
5
Palermo
90127
Italy
+39 (0)3927667467
giuseppe.dibuono@unipa.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

LaCoMEStaR1

Study information

Scientific title

Feasibility and safety of laparoscopic complete mesocolic excision (CME) for right-sided colon cancer: a prospective clinical study

Acronym

LaCoMEStaR

Study hypothesis

Laparoscopic complete mesocolic excision (CME) provides better surgical specimens than standard laparoscopic hemicolectomy.

Ethics approval

Not provided at time of registration

Study design

Interventional single-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Right-sided colon cancer

Intervention

Method of randomisation: cluster randomisation:
CME group (cases): laparoscopic complete mesocolic excision and central vascular ligation
NCME group (controls): standard laparoscopic right hemicolectomy

Follow-up: variable from short-term follow-up during hospital stay or 30-days in order to obtain feasibility and safety of laparoscopic CME versus NCME; long-term follow-up in order to obtain results about oncological outcomes.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

1. Operative time (skin-to-skin) in minutes, measured from medical records at the time of surgery
2. Intraoperative blood loss in mL, measured from medical records at the time of surgery
3. Other intraoperative complications: YES or NO and type of intraoperative complications (categorical variable), measured from medical records at the time of surgery
4. Conversion rate: YES or NO and percentage, measured from medical records at the time of surgery
5. Anastomotic leakage rate: YES or NO and percentage, measured from medical records during hospital stay
6. Specimen length: length in cm of surgical specimen, from histologic examination during 30 days
7. Lymph nodes harvesting: number of lymph nodes in surgical specimen, from histologic examination during 30 days

Secondary outcome measures

Postoperative overall complications: YES or NO and type of postoperative complications (categorical variable), measured from medical records and radiologic imaging during hospital stay or 30 days

Overall trial start date

01/10/2014

Overall trial end date

31/12/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients with right-sided colon cancer

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Total final enrolment

132

Participant exclusion criteria

Open surgery, right colon resections for inflammatory bowel diseases (IBD) and associated major surgical procedures

Recruitment start date

01/01/2015

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Italy

Trial participating centre

General and Emergency Surgery - University Hospital Policlinico "P. Giaccone"
via L. Giuffrè, 5
Palermo
90127
Italy

Sponsor information

Organisation

Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo

Sponsor details

via del vespro
129
Palermo
90127
Italy
+39 (0)916552601
antonino.agrusa@unipa.it

Sponsor type

Hospital/treatment centre

Website

http://www.policlinico.pa.it/portal/

Funders

Funder type

University/education

Funder name

Università degli Studi di Palermo

Alternative name(s)

Palermo University, University of Palermo

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Italy

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/05/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/04/2020: Trial's existence confirmed by University Hospital Policlinico "P. Giaccone" of Palermo.