Clinical trial NCT04646772: Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis.
Official title: Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis. (LACC Trial)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4
Lead sponsor: Santo Spirito Hospital, Italy
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

Brief summary: The aim of the present study is to assess the post-operative outcomes (morbidity and mortality) in relation to preoperative data and the oncological outcomes (overall and disease-free survival) in patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

Detailed description: All patients that meet the inclusion criteria will be registered in a retrospective database from 2014 to 2019 (5 years) Data will be reported for every patients with colon cancer to have had either a resection of another organ or structure in addition to resection of the primary tumor, or to have had a T4 (a or b) tumour on postoperative histopathology.

Data included are patient demographics, ASA score, tumor localization, preoperative imaging, neoadjuvant treatments, type of bowel resection and adjacent organs resected, tecnique (laparoscopic/laparotomic), postoperative complications and 30-day mortality, histopathology data including TNM scoring, completeness of surgical procedure (R0 to R2) and infiltration of tumor cells in resected tissues, adjuvant oncological treatments, and long term follow-up data on local and distant recurrence and survival.

Eligibility criteria: Inclusion criteria

* \> 18 aa
* Patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

Exclusion criteria

* Stage IV
* Rectal cancer
* Emergency surgery (\<48 hours from admission)
* ASA \> III

Primary outcomes:
measure: Postoperative morbidity
timeFrame: 30 days
measure: Postoperative mortality
timeFrame: 30 days
Secondary outcomes:
measure: Overall Survival
timeFrame: 5 years
measure: Disease Free Survival
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
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