RecruitingNot ApplicableNCT06325982

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


Sponsor

Fujian Cancer Hospital

Enrollment

200 participants

Start Date

Jun 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Inclusion Criteria5

  • 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 Criteria6

  • 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.

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Interventions

DRUGTriethanolamine 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.


Locations(1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

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NCT06325982


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