Comparison between laparoscopic complete mesocolic excision versus standard laparoscopic colonic resection for right-sided colon cancer
| ISRCTN | ISRCTN71842827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71842827 |
| Secondary identifying numbers | LaCoMEStaR1 |
- Submission date
- 30/03/2020
- Registration date
- 07/04/2020
- Last edited
- 11/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Via L. giuffrè, 5
Palermo
90127
Italy
 ORCID ID |
0000-0001-9928-6448 |
|---|---|
| Phone | +39 (0)3927667467 |
| giuseppe.dibuono@unipa.it |
Study information
| Study design | Interventional single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Feasibility and safety of laparoscopic complete mesocolic excision (CME) for right-sided colon cancer: a prospective clinical study |
| Study acronym | LaCoMEStaR |
| Study objectives | Laparoscopic complete mesocolic excision (CME) provides better surgical specimens than standard laparoscopic hemicolectomy. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2014 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 132 |
| Key inclusion criteria | Patients with right-sided colon cancer |
| Key exclusion criteria | Open surgery, right colon resections for inflammatory bowel diseases (IBD) and associated major surgical procedures |
| Date of first enrolment | 01/01/2015 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- Italy
Study participating centre
Palermo
90127
Italy
Sponsor information
Hospital/treatment centre
via del vespro, 129
Palermo
90127
Italy
| Phone | +39 (0)916552601 |
|---|---|
| antonino.agrusa@unipa.it | |
| Website | http://www.policlinico.pa.it/portal/ |
"ROR" |
https://ror.org/05p21z194 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Palermo University, University of Palermo
- Location
- Italy
Results and Publications
| Intention to publish date | 30/05/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2021 | 11/08/2021 | Yes | No |
Editorial Notes
11/08/2021: Publication reference added.
06/04/2020: Trial's existence confirmed by University Hospital Policlinico "P. Giaccone" of Palermo.
