Colorectal CancerNCT05744362
Outcome of Transanal Specimen Extraction Surgery for Elderly Colorectal Cancer Patients
An observational study of Colorectal Cancer, run by The Second Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
Retrospective analysis of a cohort of elderly CRC patients (aged ≥ 65 years) underwent transanal-NOSES between August 2008 and February 2022 was constructed. Data were obtained from China NOSES Database (CNDB). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 1,395 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 1 Jan 2023
- 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 65 years and older
- All sexes
- Older adult
Study population: elderly CRC patients with transanal-NOSES surgery
Who may be able to join
- patients diagnosed as T1-4N0-2M0 colorectal cancer pathologically
- patients underwent transanal-NOSES
- patients aged 65 years or older
Who cannot join
- patients with multiple primary colorectal cancer
- patients with total colectomy
- patients without complete data
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
About this study
Official title: Outcome of Transanal Specimen Extraction Surgery for Elderly Colorectal Cancer Patients: a National Database Study in China of 1395 Cases
Retrospective analysis of a cohort of elderly CRC patients (aged ≥ 65 years) underwent transanal-NOSES between August 2008 and February 2022 was constructed. Data were obtained from China NOSES Database (CNDB). The primary outcomes included time to first flatus, postoperative hospital stays, 30-day postoperative complication and hospital mortality. The secondary outcomes were overall survival (OS) and disease-free survival (DFS).
- Conditions
- Colorectal Cancer
- Keywords
- survival
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time of death from any cause after survival
Measured: 4-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Nov 2022
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 1,395 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Hao, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744362
- Sponsor's protocol ID
- KY2022-313
- Status last verified
- Dec 2022
- First submitted
- 7 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Transanal Specimen Extraction Surgery for Elderly Colorectal Cancer Patients: a National Database Study in China of 1395 Cases
- ClinicalTrials.gov ID
- NCT05744362
- Acronym / sponsor ID
- KY2022-313
- Conditions
- Colorectal Cancer
- Keywords
- survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,395 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 27 Feb 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.
Retrospective analysis of a cohort of elderly CRC patients (aged ≥ 65 years) underwent transanal-NOSES between August 2008 and February 2022 was constructed. Data were obtained from China NOSES Database (CNDB). The primary outcomes included time to first flatus, postoperative hospital stays, 30-day postoperative complication and hospital mortality. The secondary outcomes were overall survival (OS) and disease-free survival (DFS).
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- elderly CRC patients with transanal-NOSES surgery
Key inclusion criteria (3 listed)
- patients diagnosed as T1-4N0-2M0 colorectal cancer pathologically
- patients underwent transanal-NOSES
- patients aged 65 years or older
Key exclusion criteria (3 listed)
- patients with multiple primary colorectal cancer
- patients with total colectomy
- patients without complete data
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
Overall survival
Time frame: 4-year
Time of death from any cause after survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Colorectal Cancer, run by The Second Affiliated Hospital of Harbin Medical University 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 3 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: finished, as of the sponsor's last update on 27 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 4-year). 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 27 Feb 2023.