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

NCT05801211 | Unknown

• 1 other identifier: Alessio Giordano
• Study Type: observational
• Target: 434
• Locations: 0 countries
• Sites: N/A

Brief 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

Colon Cancer

Keywords

SEMS; obstructive CRC; primary anastomosis; Hartmann

Outcome Measures

Primary Outcomes (1)

• Stoma rate at 1 year after tumor resection

  the number of stomas after 1 year of primary surgery with tumor resection

  1 year

Secondary Outcomes (5)

• 30-day and 90-day major morbidity

  30-days; 90-days

• 30-day and 90-day mortality

  30-days; 90-days

• 1-year quality of life (The 5-level EQ-5D version (EQ-5D-5L)test)

  1-year

• Timing of chemotherapy initiation

  2-years

• type of chemotherapy regimen

  2-years

Study Arms (2)

primary surgical tumor resection with anastomosis or only tumor resection without anastomosis

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")

Procedure: primary tumor resection

endoscopic stent positioning

staged resection after endoscopic stenting with Self-expandable Metallic Stent (SEMS)

Interventions

primary tumor resection PROCEDURE

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")

primary surgical tumor resection with anastomosis or only tumor resection without anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes all consecutive adult patients (≥18 years of age) presenting acutely ( unplanned and non-elective presentation to hospital for urgent or emergency reasons) at the participating centers with a clinical and radiological diagnosis of (known or unknown descending or sigmoid colon tumor) for 1 year. According to the different management methods, the cohort will be divided into the following categories: 1. Primary tumor resection, which will include patients treated with Hartmann's procedure or primary resection with anastomosis (with or without a diverting ileostomy). 2. Staged tumor resection, which will include patients treated with a Self-expandable Metallic Stent (SEMS) insertion, followed by colorectal resection.

You may qualify if:

• Patients of both sexes, ≥ 18 years old.
• Patients with abdominal CT scan diagnosis of colonic obstruction due to obstructive left colonic cancer (sigmoid or descending colon).
• Absence of distant metastases on abdominal and chest CT scan.
• Patients who may face a one-year follow-up.
• Patients fit for surgery.
• Patients with colonic adenocarcinoma on postoperative histological examination.

You may not qualify if:

• Right-side or trasverse colon cancer.
• Surgical or endoscopic palliation in patients with peritoneal carcinomatosis, locally advanced Colorectal cancer (CRC) (T4 sec. TNM), M1 disease.
• Bowel obstruction determinated by other tumors or benign inflammatory stenosis.
• Concomitant bowel abscess, perforation, or fistula.
• Elective procedures.
• Pregnancy or lactation.

Sponsors & Collaborators

• Azienda Sanitaria di Firenze: lead

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Alessio Giordano

  AOU Careggi Firenze

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessio Giordano

CONTACT

+390557949173; alessio.giordano8@gmail.com

Sfogli Anna

CONTACT

+39055794111; sfoglia@aou-careggi.toscana.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 6, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD can be Share for 1 year after follow up closure
• Access Criteria: by email with colleagues who will be interested