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Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury

NCT06325982 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-06-05

No results posted yet for this study

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.

Conditions

  • Radiation Injuries
  • Rectal Diseases

Interventions

DRUG

Triethanolamine cream

Triethanolamine cream retention enema was given once every night before going to bed during radiotherapy until the end of radiotherapy. Triethanolamine cream retention enema was given once before going to bed the day after radiotherapy for 3 months. Preparation method: Pull out the syringe piston, add 15ml triethanolamine cream, add 30ml normal saline, gently pat, shake well. Specific methods of retention enema: at night before going to bed, empty urine and feces, prepare enema liquid into the syringe, connect the special catheter, and insert the other end of the special catheter into the anus (the special catheter can be applied with lubricant such as tea oil before insertion). The patient remained prone and semi-seated. Use a special catheter, insert a special catheter about 15cm from the anus, and inject enteral liquid while withdrawing, so that the liquid is retained in the rectum; The above treatment was performed before bed and retained overnight.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • lingdong Shao, Bachelor · Fujian Cancer Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-11
Primary Completion
2025-05-01
Completion
2025-12-31

Countries

  • China

Study Locations

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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 NCT06325982 on ClinicalTrials.gov