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

NCT ID: NCT05801211

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 434 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-05-01

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.

Detailed Description

Since surgical and oncological outcomes of the different treatment strategies for obstructing left colon cancers have not been studied on a large scale globally, we launched the CROSCO-1 study intending to compare the clinical results of all these therapeutic regimens in a cohort of patients treated for obstructive left-sided colorectal cancer (CRC).

The primary aim of the CROSCO-1 (Colonic Resection, stOma or self-expanding metal Stents for obstruCtive left cOlon cancer) study is to describe the outcomes of the management of emergency presentations of obstructive left CRC with colorectal resection with or without primary anastomosis versus the staged approach with SEMS insertion and subsequent colorectal resection. The primary aim of the CROSCO-1 study will be the 1-year stoma rate of patients undergoing primary emergency surgical resection (Hartmann procedure or primary resection and anastomosis) compared with patients undergoing staged resection (emergency endoscopic treatment with SEMS followed by elective resection). Other outcomes will be 30-day and 90-day major morbidity and mortality, 1-year quality of life, and the timing and type of chemotherapy initiation in the two groups.

Conditions

Colon Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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")

primary tumor resection

Intervention Type: 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")

endoscopic stent positioning

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

No interventions assigned to this group

Interventions

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")

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients of both sexes, ≥ 18 years old.

2. Patients with abdominal CT scan diagnosis of colonic obstruction due to obstructive left colonic cancer (sigmoid or descending colon).

3. Absence of distant metastases on abdominal and chest CT scan.

4. Patients who may face a one-year follow-up.

5. Patients fit for surgery.

6. Patients with colonic adenocarcinoma on postoperative histological examination.

Exclusion Criteria

1. Right-side or trasverse colon cancer.

2. Surgical or endoscopic palliation in patients with peritoneal carcinomatosis, locally advanced Colorectal cancer (CRC) (T4 sec. TNM), M1 disease.

3. Bowel obstruction determinated by other tumors or benign inflammatory stenosis.

4. Concomitant bowel abscess, perforation, or fistula.

5. Elective procedures.

6. Pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Sanitaria di Firenze

OTHER

Sponsor Role: lead

Responsible Party

Alessio Giordano

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessio Giordano

Role: PRINCIPAL_INVESTIGATOR

AOU Careggi Firenze

Central Contacts

Alessio Giordano

Role: CONTACT

alessio.giordano8@gmail.com

+390557949173

Sfogli Anna

Role: CONTACT

sfoglia@aou-careggi.toscana.it

+39055794111

Other Identifiers

Alessio Giordano

Identifier Type: -

Identifier Source: org_study_id