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Effects of Different Treatment for Anorectal Function of Patients With Rectal Cancer

NCT05671809 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 402

Last updated 2023-01-05

No results posted yet for this study

Summary

Background

Neoadjuvant chemoradiotherapy (NCRT) and total mesorectal excision are standard treatments for patients with locally advanced rectal cancer. These sphincter-saving operations may be accompanied by a series of functional disorders. Prospective studies dynamically evaluating the different roles of surgery and NCRT on anorectal function are lacking.

Methods/design

The study is a prospective, observational, controlled, multicentre study. After screening for eligibility and obtaining informed consent, a total of 402 rectal cancer patients aged from 18 to 75 years old undergoing sphincter preservation treatments at The Sixth Affiliated Hospital, Sun Yat-sen University and Nanfang Hospital, Southern Medical University are included in the trial. The primary outcome measure is the average resting pressure of anal sphincter. The secondary outcome measures are maximum anal sphincter contraction pressure and Wexner continence score. Evaluations will be carried out at the following stages: baseline (T1), after radiotherapy or chemotherapy (before surgery, T2), after surgery (before closing the temporary stoma, T3), and at follow-up visits (every 3 to 6 months, T4, T5……). Follow-up for each patient will be at least 2 years.

Discussion

We expect the program to provide more information on therapeutical options and strategies to reduce anorectal dysfunction of rectal cancer patients who have been undergone sphincter preservation treatments.

Conditions

Interventions

OTHER

NCRT with surgery, or NCT with surgery, or surgery

The eligible patients who voluntarily sign the consent form will undergo either NCRT with surgery, or NCT with surgery, or surgery according to treatment guidelines.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Xin-juan Fan, Ph.D · The Sixth Affiliated Hospital, Sun Yat-sen University

  • Xiang-Bo Wan, Ph.D · The Sixth Affiliated Hospital, Sun Yat-sen University

  • Hong-Cheng Lin, Ph.D · The Sixth Affiliated Hospital, Sun Yat-sen University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-12-31
Completion
2026-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05671809 on ClinicalTrials.gov