Status:
RECRUITING
Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
Radiation Injuries
Rectal Diseases
Eligibility:
All Genders
Phase:
NA
Brief Summary
The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world.
Detailed Description
The study was a prospective, multicenter, real-world study with eligible patient data as of May 1, 2024. The prospective study was a continuous, multicenter study.
Eligibility Criteria
Inclusion Criteria:
- There are clear indications for radiotherapy (pelvic radiotherapy or rectal radiotherapy) according to relevant guidelines;
- ECOG score 0-1;
- normal mind, clear consciousness;
- High compliance;
- Able to cooperate with the interviewer
Exclusion Criteria:
- Poor compliance, unwilling to participate or unable to cooperate with the interviewer;
- Patients with other intestinal diseases (such as Crohn's disease, rectal ulcer, anal fissure, anal fistula, hemorrhoids, etc.) and perianal diseases;
- serious heart, brain, liver, kidney disease;
- Long-term immune dysfunction;
- Pregnant or lactating women;
- Patients who terminate treatment for various reasons.
Key Trial Info
Start Date :
June 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06325982
Start Date
June 11 2024
End Date
December 31 2025
Last Update
June 5 2024
Active Locations (1)
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1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003