Clinical trial · Observational

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

Colonic Resection, stOma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer. The CROSCO-1 Multicenter, Prospective Cohort Study

NCT05801211CI-TRIAL-00065614CROSCO-1unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Colon Cancer	Malignant Colon Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
primary tumor resection	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
primary surgical tumor resection with anastomosis or only tumor resection without anastomosis
description
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")
interventionNames
1. Procedure: primary tumor resection
label
endoscopic stent positioning
description
staged resection after endoscopic stenting with Self-expandable Metallic Stent (SEMS)

Primary outcomes (1)

measure
Stoma rate at 1 year after tumor resection
timeFrame
1 year
description
the number of stomas after 1 year of primary surgery with tumor resection

Secondary outcomes (5)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (1)

DERIVEDGiordano A, Mastronardi M, Fugazzola P, Montori G, Agresta F, Martellucci J, Catena F, Coccolini F, Anania G, Costa G, Bottino V, Cillara N, Prosperi P, Bergamini C, Podda M; CROSCO-1 Collaborative Group. Colonic resection or self-expanding metal stents for obstructive left colon cancer: results of a national multicenter prospective cohort study (CROSCO-1). Surg Endosc. 2026 Jun 3. doi: 10.1007/s00464-026-12929-9. Online ahead of print. PMID 42236555