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

Phase 4

• Conditions: The Influence of Timing of Botulinum Toxin Injection on Postoperative Pain Control
• Interventions: Biological: botulinum toxin type A

• Registration Number: NCT04485780
• Lead Sponsor: Tri-Service General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-08
• Status Verified: 2020-07
• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-21
• Last Update Submitted: 2020-07-21
• Study First Posted: 2020-07-24
• Last Update Posted: 2020-07-24
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients with age over 20 but under 80, who need to undergo hemorrhoidectomy

Read More

Exclusion Criteria

• patients under the age of 20
• patients with nonsteroidal anti-inflammatory drugs (NSAIDs) allergy or sensitivity
• patients with Botulinum toxin allergy or sensitivity
• patients with dialysis or renal insufficiency
• pregnant and breastfeeding women
• vulnerable population

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin injection during surgery	botulinum toxin type A	Patients in this group underwent Botulinum toxin injection during surgery
Botulinum toxin injection one week before surgery	botulinum toxin type A	Patients in this group underwent Botulinum toxin injection at the outpatient clinic one week before surgery

Primary Outcome Measures

Name	Time	Method
one week after operation	1 weel	The degree of postoperative pain is assessed by visual analog scale (VAS). After operation, we record patients' average VAS score and maximum VAS score every day until one week after surgery.

Trial Locations

Locations (1)

Tri-Service General Hospital, National Defense Medical Center; 🇨🇳 Taipei, Taiwan