Colonic Resection or Stoma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer (CROSCO-1)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colon Cancer
• Intervention / Treatment: Procedure: primary tumor resection

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.

• Study Type: Observational
• Enrollment (Anticipated): 434

Contacts and Locations

• Study Contact: Name: Alessio Giordano; Phone Number: +390557949173; Email: alessio.giordano8@gmail.com
• Study Contact Backup: Name: Sfogli Anna; Phone Number: +39055794111; Email: sfoglia@aou-careggi.toscana.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stoma rate at 1 year after tumor resection	the number of stomas after 1 year of primary surgery with tumor resection	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day and 90-day major morbidity	morbidity after 30 and 90-days	30-days; 90-days
30-day and 90-day mortality	mortality (Overall survival) after 30 and 90-days	30-days; 90-days
1-year quality of life (The 5-level EQ-5D version (EQ-5D-5L)test)	The EQ-5D-5L is an instrument to describe the quality of life with a state system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. In this first part, the patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions with graduate answers from 1 (no problem) to 5 (extreme limitations). The aggregation of the responses forms a five-digit number representing the patient's health status. in the second part, the patient is asked to indicate an assessment using a visual analog (VAS) graphically represented by a graduated scale ranging from 0 (the worst possible state of health) to 100 (the best possible state of health) on which the interviewee indicates his or her perceived level of health.	1-year
type of chemotherapy regimen	type of drugs regimen in both groups of study	2-years
Timing of chemotherapy initiation	data for chemotherapy initiation in both groups of study	2-years

Collaborators and Investigators

• Sponsor: Azienda Sanitaria di Firenze
• Investigators: Principal Investigator: Alessio Giordano, AOU Careggi Firenze

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: SEMS; primary anastomosis; obstructive CRC; Hartmann
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: Alessio Giordano

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all individual participant data (IPD) that underlie results in a publication
• IPD Sharing Time Frame: IPD can be Share for 1 year after follow up closure
• IPD Sharing Access Criteria: by email with colleagues who will be interested
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No