Colon CancerCROSCO-1NCT05801211
Colonic Resection or Stoma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer
An observational study of Colon Cancer, run by Azienda Sanitaria di Firenze.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- primary tumor resection
- Type of treatment
- Surgery or procedure
- How many people
- 434 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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:
Read more
- 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.
Read the 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
- Being tested
- primary tumor resection
- Keywords
- SEMS, obstructive CRC, primary anastomosis, Hartmann
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary tumor resectionProcedure or surgery
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")
| Study group | Role | What they receive |
|---|---|---|
| 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") Receives: Procedure: primary tumor resection | |
| endoscopic stent positioning | staged resection after endoscopic stenting with Self-expandable Metallic Stent (SEMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stoma rate at 1 year after tumor resection
the number of stomas after 1 year of primary surgery with tumor resection
Measured: 1 year
Secondary outcomes (5)
30-day and 90-day major morbidity
morbidity after 30 and 90-days
Measured: 30-days; 90-days
30-day and 90-day mortality
mortality (Overall survival) after 30 and 90-days
Measured: 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.
Measured: 1-year
Timing of chemotherapy initiation
data for chemotherapy initiation in both groups of study
Measured: 2-years
type of chemotherapy regimen
type of drugs regimen in both groups of study
Measured: 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria di Firenze
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessio Giordano, Azienda Sanitaria di Firenze
- Investigators
- Alessio Giordano, Principal investigator, AOU Careggi Firenze
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801211
- Sponsor's protocol ID
- Alessio Giordano
- Acronym
- CROSCO-1
- Status last verified
- Apr 2023
- First submitted
- 8 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data (IPD) that underlie results in a publication
Publications
Giordano 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.
PubMed 42236555
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonic Resection, stOma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer. The CROSCO-1 Multicenter, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05801211
- Acronym / sponsor ID
- CROSCO-1 / Alessio Giordano
- Conditions
- Colon Cancer
- Keywords
- SEMS, obstructive CRC, primary anastomosis, Hartmann
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- Azienda Sanitaria di FirenzeUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary surgical tumor resection with anastomosis or only tumor resection without anastomosis | – | Procedure: primary tumor resectionprimary 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| primary tumor resectionprimary 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 or surgery | primary surgical tumor resection with anastomosis or only tumor resection without anastomosis |
Primary outcome
Stoma rate at 1 year after tumor resection
Time frame: 1 year
the number of stomas after 1 year of primary surgery with tumor resection
5 secondary outcomes
30-day and 90-day major morbidity
Time frame: 30-days; 90-days
30-day and 90-day mortality
Time frame: 30-days; 90-days
1-year quality of life (The 5-level EQ-5D version (EQ-5D-5L)test)
Time frame: 1-year
Timing of chemotherapy initiation
Time frame: 2-years
type of chemotherapy regimen
Time frame: 2-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Derived from this study: PubMed 42236555Giordano 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.
- Individual participant dataSharing planned: Yes. all individual participant data (IPD) that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessio Giordano principal investigator
AOU Careggi Firenze
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Azienda Sanitaria di Firenze.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessio Giordano (+390557949173, alessio.giordano8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stoma rate at 1 year after tumor resection (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05801211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.