NCT07440888

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
17 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

17 years

First QC Date

September 3, 2025

Last Update Submit

February 25, 2026

Conditions

Colo-rectal CancerAnastomosis, Leaking

Outcome Measures

Primary Outcomes (1)

  • Whether postoperative patients with rectal cancer can restore intestinal continuity, that is, defecate through the anus

    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

    During the follow-up period, at least one year has passed since the intestinal continuity was restored

Interventions

redo surgeryPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Prior curative resection for primary colorectal adenocarcinoma.
  • Subsequent reoperation for anastomotic failure or locoregional recurrence.
  • Absence of absolute contraindications to reoperative surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2025

First Posted

February 27, 2026

Study Start

March 1, 2006

Primary Completion

March 1, 2023

Study Completion

December 31, 2023

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share