NCT05671809Not yet recruiting
Effects of Different Treatment for Anorectal Function of Patients With Rectal Cancer
Effects of Different Treatment for Anorectal Function of Patients With Rectal Cancer: a Study Protocol for a Prospective, Observational, Controlled, Multicentre Study
Source: ClinicalTrials.gov · Last updated 5 Jan 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 402 (estimated)
- First submitted
- 3 Jan 2023
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT05671809
What you commit to
- Study type: Observational
- Planned participants: 402
- From 1 Jan 2023 to the primary completion date, 31 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have undergone rectal cancer surgery. Patients who have received pelvic radiotherapy. Patients with other active malignant tumors. Recently (less than 4 weeks) received surgery or patients with recent severe trauma.
- Patients with toxicity (CTCAE Grade ≥ 2) caused by previous treatment that has not subsided.
Other illness
- Significant cardiac disease: congestive heart failure of New York Heart Association class ≥2; patients with recent (less than 12 months) active coronary artery disease (unstable angina or myocardial infarction).
- Recent (less than 6 months) thrombosis or embolism events, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism and deep vein thrombosis.
Other
- Pregnant or lactating women.
Who the study is looking for
- 18-75 years of age. Rectal cancer with pathological diagnosis. Patient will undergo sphincter-preserving therapies. ECOG score for performance status is 0-2. Written informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.