MedTrace Logo

Colonic Resection or Stoma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer

NCT05801211 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 434

Last updated 2023-04-13

No results posted yet for this study

Summary

CROSCO-1 study is a national, multi-center, prospective observational study presenting patients to the emergency departments of the participating centers with obstructive left colon cancer (in the absence of metastases and peritoneal carcinomatosis) undergoing primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or without a primary anastomosis ("Hartmann's procedure") or staged resection after endoscopic stenting with Self-expandable Metallic Stent (SEMS).

The main questions it aims to answer are:

* the Stoma rate at 1 year after tumor resection
* the 30-day and 90-day major morbidity and mortality
* 1-year quality of life (EQ-5D-5L test)
* Timing of chemotherapy initiation and type of chemotherapy regimen. Participants will have an obstructive left colon cancer localized (no peritoneal carcinosis or distant metastasis).

Researchers will compare: primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or an "Hartmann's procedure" with a staged resection after endoscopic stenting with SEMS.

Conditions

Interventions

PROCEDURE

primary tumor resection

primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or without a primary anastomosis ("Hartmann's procedure")

Sponsors & Collaborators

  • Azienda Sanitaria di Firenze

    lead OTHER

Principal Investigators

  • Alessio Giordano · AOU Careggi Firenze

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2024-05-01
Completion
2025-05-01

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05801211 on ClinicalTrials.gov