Colorectal CancerNCT07279961
A Multicenter Study on the Safety and Functionality Evaluation of Anastomotic Redo Surgery
An observational study of Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
To analyze the influencing factors of the success of redo surgery due to anastomotic fistula or anastomotic recurrence after rectal cancer surgery and to evaluate the anal function of patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2006to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective, multicenter study analyzed data from a prospectively maintained redo surgery registry spanning March 2015 to March 2023. Patients were recruited from Cancer Hospital Chinese Academy of Medical Sciences,Sun Yat-sen University Sixth Affiliated Hospital and Yifu Hospital Affiliated to Nanjing Medical University.
Who may be able to join
- Prior curative resection for primary colorectal adenocarcinoma.
- Subsequent reoperation for anastomotic failure or locoregional recurrence.
- Absence of absolute contraindications to reoperative surgery.
Who cannot join
- Primary tumors located proximal to the sigmoid colon.
- Radiologically confirmed distant metastases.
- Presence of a permanent stoma at the time of questionnaire administration.
- Insufficient literacy or cognitive function to complete study-related -questionnaires.
About this study
Official title: A Multicenter Retrospective Study in China: the Factors Influencing the Success of Redo Surgery and Anal Function for Anastomosis Failure or Local Tumor Recurrence
To analyze the influencing factors of the success of redo surgery due to anastomotic fistula or anastomotic recurrence after rectal cancer surgery and to evaluate the anal function of patients
Read the detailed description
Redo surgery is a critical salvage strategy for anastomotic complications or local recurrence following rectal cancer resection. Despite technical feasibility, functional outcomes remain suboptimal. This study evaluated intestinal continuity restoration and anal function recovery after redo surgery, alongside prognostic factors influencing outcomes. A retrospective multicenter study analyzed 143 patients undergoing redo surgery (2015-2023) for anastomotic failure or local recurrence. Primary endpoints included anatomical restoration of intestinal continuity, while secondary endpoints assessed functional outcomes using the LARS score.
- Conditions
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether postoperative patients with rectal cancer can restore intestinal continuity, that is, defecate through the anus
Measured: During the follow-up period, at least two years after rectal cancer surgery
Secondary outcomes (1)
Low Anterior Rectal Syndrome (LARS) Score of patients restoring intestinal continuity
Measured: During the follow-up period, at least one year has passed since the intestinal continuity was restored
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 May 2006
- Primary completion1 Mar 2023
- Study completion31 Dec 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279961
- Sponsor's protocol ID
- NCCH-000166
- Status last verified
- Nov 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Retrospective Study in China: the Factors Influencing the Success of Redo Surgery and Anal Function for Anastomosis Failure or Local Tumor Recurrence
- ClinicalTrials.gov ID
- NCT07279961
- Acronym / sponsor ID
- NCCH-000166
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 May 2006 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Dec 2025 (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.
To analyze the influencing factors of the success of redo surgery due to anastomotic fistula or anastomotic recurrence after rectal cancer surgery and to evaluate the anal function of patients
Detailed description
Redo surgery is a critical salvage strategy for anastomotic complications or local recurrence following rectal cancer resection. Despite technical feasibility, functional outcomes remain suboptimal. This study evaluated intestinal continuity restoration and anal function recovery after redo surgery, alongside prognostic factors influencing outcomes. A retrospective multicenter study analyzed 143 patients undergoing redo surgery (2015-2023) for anastomotic failure or local recurrence. Primary endpoints included anatomical restoration of intestinal continuity, while secondary endpoints assessed functional outcomes using the LARS score.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective, multicenter study analyzed data from a prospectively maintained redo surgery registry spanning March 2015 to March 2023. Patients were recruited from Cancer Hospital Chinese Academy of Medical Sciences,Sun Yat-sen University Sixth Affiliated Hospital and Yifu Hospital Affiliated to Nanjing Medical University.
Key inclusion criteria (3 listed)
- Prior curative resection for primary colorectal adenocarcinoma.
- Subsequent reoperation for anastomotic failure or locoregional recurrence.
- Absence of absolute contraindications to reoperative surgery.
Key exclusion criteria (4 listed)
- Primary tumors located proximal to the sigmoid colon.
- Radiologically confirmed distant metastases.
- Presence of a permanent stoma at the time of questionnaire administration.
- Insufficient literacy or cognitive function to complete study-related -questionnaires.
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
Whether postoperative patients with rectal cancer can restore intestinal continuity, that is, defecate through the anus
Time frame: During the follow-up period, at least two years after rectal cancer surgery
1 secondary outcome
Low Anterior Rectal Syndrome (LARS) Score of patients restoring intestinal continuity
Time frame: During the follow-up period, at least one year has passed since the intestinal continuity was restored
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 12 Dec 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 4 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 12 Dec 2025. 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?
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?
Whether postoperative patients with rectal cancer can restore intestinal continuity, that is, defecate through the anus (time frame: During the follow-up period, at least two years after rectal cancer surgery). 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 12 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.