- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07440888
The Factors Influencing the Success of Redo Surgery and Anal Function for Anastomosis Failure or Local Tumor Recurrence
February 25, 2026 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
143
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Prior curative resection for primary colorectal adenocarcinoma.
- Subsequent reoperation for anastomotic failure or locoregional recurrence.
- Absence of absolute contraindications to reoperative surgery.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
During the follow-up period, at least two years after rectal cancer surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
During the follow-up period, at least one year has passed since the intestinal continuity was restored
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2006
Primary Completion (Actual)
March 1, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
September 3, 2025
First Submitted That Met QC Criteria
February 25, 2026
First Posted (Actual)
February 27, 2026
Study Record Updates
Last Update Posted (Actual)
February 27, 2026
Last Update Submitted That Met QC Criteria
February 25, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC25721
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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