drugset / Trial / NCT04485780

Botulinum Toxin Injection in Patients Undergoing Hemorrhoidectomy-A Prospective, Randomized Study

NCT04485780 ↗

Phase 4 Unknown 60 enrolled Tri-Service General Hospital (TSGH)
RandomizedParallel-groupTriple-blindPrevention

Summary

This is a prospective, randomized study, which anticipatedly recruited 60 patients in the outpatient department who need hemorrhoidectomy from January 2019 to December 2019. After obtaining those patients' consent in the clinic, they were randomly assigned to two groups at a 1:1 ratio using a computer-generated list of random numbers (Microsoft Excel). One group received Botulinum toxin injection during the outpatient clinic one week before the operation(experimental group, EG), and the other group received injection during the operation(control group, CG). The two groups were compared for the influence of postoperative pain control and wound healing rate.

Timeline

Start
2018-10-08
Primary completion
2021-12-31
Completion
2021-12-31

Outcome

Met primary endpoint

paper yielded a significantly lower maximal (OR 0.4, 95% CI 0.2-1.0, p = 0.041) and resting (OR 0.4, 95% CI 0.2-0.7, p < 0.001) VAS compared to controls PMID 34705137 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 50 iu Other

Indications

No indication recorded.