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

• Conditions: Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4

• Registration Number: NCT04646772
• Lead Sponsor: Santo Spirito Hospital, Italy

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 Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-11-30
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-01
• Study Start: 2021-01-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative mortality	30 days	I evaluate in-hospital and 30-day mortality correlate to the intervention
Postoperative morbidity	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

Secondary Outcome Measures

Name	Time	Method
Overall Survival	5 years	The length of time from the intervention that patients diagnosed with a T4 colon cancer are still alive.
Disease Free Survival	5 years	The measure of time after treatment during which no sign of recurrence (local or metastatic) is found.