NCT06325982

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

Clinical Observation of Trolamine Retention Enema in Preventing Acute Radiation-induced Rectal Injury: a Real-world Multicenter Prospective Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Radiation Injuries
• Rectal Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-11
• Primary completion: 2025-05-01
• Completion: 2025-12-31
• First posted: 2024-03-22
• Last updated: 2024-06-05

Locations

1 site across 1 country: China