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Clinical Trials/NCT04646772
NCT04646772
Unknown
Not Applicable

Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis. (LACC Trial)

Santo Spirito Hospital, Italy0 sites100 target enrollmentStarted: January 1, 2021Last updated:

Overview

Phase
Not Applicable
Sponsor
Santo Spirito Hospital, Italy
Enrollment
100
Primary Endpoint
Postoperative morbidity

Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Postoperative morbidity

Time Frame: 30 days

I evaluate peri and post-operative surgical (e.g. intraabdominal collection, fistula, anastomotic leak) and medical (e.g. pneumoniae, deep vein thrombosis) complications

Postoperative mortality

Time Frame: 30 days

I evaluate in-hospital and 30-day mortality correlate to the intervention

Secondary Outcomes

  • Overall Survival(5 years)
  • Disease Free Survival(5 years)

Investigators

Sponsor
Santo Spirito Hospital, Italy
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Francesca Cravero

Dirigente Medico I livello Chirurgia Generale

Santo Spirito Hospital, Italy

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