Rectal CancerNCT06194708
Reasons for Non-reversal of Temporary Stomas After Surgeries of Mid-low Rectal Cancer （NORESTO Study）
An observational study of Rectal Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about in mid-low rectal patients who received temporary ostomies after surgery of the primary tumors. The main questions it aims to answer are: To explore the proportion of temporary stomas that cannot be reversed after radical surgery for mid-low rectal cancer and… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rectal Cancer
- How many people
- 235 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2023to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In-hospital rectal cancer patients who underwent radical resection of the primary lesion
Who may be able to join
- Pathologically confirmed as rectal adenocarcinoma;
- The tumor is located within 12cm from the anal verge;
- Primary tumor is radically resected;
- The patient received a temporary ostomy during the in-hospital visit of the resection of the primary tumor.
Who cannot join
- The stoma was initially recognized as permanent stoma;
- Patients with distant metastasis;
- Patients with multi-primary colorectal cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xiao Yi, +86 13366036387, xiaoy@pumch.cn
About this study
Official title: Reasons for Non-reversal of Temporary Stomas After Surgeries of Mid-low Rectal Cancer （NORESTO Study）on Behalf of Chinese Ostomy Collaboration Group (COCG-02)
The goal of this observational study is to learn about in mid-low rectal patients who received temporary ostomies after surgery of the primary tumors. The main questions it aims to answer are:
- To explore the proportion of temporary stomas that cannot be reversed after radical surgery for mid-low rectal cancer and their main causes.
- To use the basic information we collected from patients before and during surgery to develop an individualized model for predicting the time of stoma reversal and explore the risk factors affecting stoma reversal.
- Conditions
- Rectal Cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mid-low rectal cancer patients with temporary stoma after radical surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year non-reversal rate of temporary stoma
Measured: 1 year after ostomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start15 May 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194708
- Sponsor's protocol ID
- COCG-02
- Status last verified
- Jan 2023
- First submitted
- 22 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reasons for Non-reversal of Temporary Stomas After Surgeries of Mid-low Rectal Cancer （NORESTO Study）on Behalf of Chinese Ostomy Collaboration Group (COCG-02)
- ClinicalTrials.gov ID
- NCT06194708
- Acronym / sponsor ID
- COCG-02
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 8 Jan 2024 (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.
The goal of this observational study is to learn about in mid-low rectal patients who received temporary ostomies after surgery of the primary tumors. The main questions it aims to answer are:
- To explore the proportion of temporary stomas that cannot be reversed after radical surgery for mid-low rectal cancer and their main causes.
- To use the basic information we collected from patients before and during surgery to develop an individualized model for predicting the time of stoma reversal and explore the risk factors affecting stoma reversal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mid-low rectal cancer patients with temporary stoma after radical surgery | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In-hospital rectal cancer patients who underwent radical resection of the primary lesion
Key inclusion criteria (4 listed)
- Pathologically confirmed as rectal adenocarcinoma;
- The tumor is located within 12cm from the anal verge;
- Primary tumor is radically resected;
- The patient received a temporary ostomy during the in-hospital visit of the resection of the primary tumor.
Key exclusion criteria (3 listed)
- The stoma was initially recognized as permanent stoma;
- Patients with distant metastasis;
- Patients with multi-primary colorectal cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1-year non-reversal rate of temporary stoma
Time frame: 1 year after ostomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year non-reversal rate of temporary stoma (time frame: 1 year after ostomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2024.