The Optimal Timing of Botulinum Toxin Injection for Pain Control in Patients Undergoing Hemorrhoidectomy-A Prospective, Randomized Study
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Tri-Service General Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- one week after operation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •patients with age over 20 but under 80, who need to undergo hemorrhoidectomy
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
Arms & Interventions
Botulinum toxin injection one week before surgery
Patients in this group underwent Botulinum toxin injection at the outpatient clinic one week before surgery
Intervention: botulinum toxin type A (Biological)
Botulinum toxin injection during surgery
Patients in this group underwent Botulinum toxin injection during surgery
Intervention: botulinum toxin type A (Biological)
Outcomes
Primary Outcomes
one week after operation
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Yi-Chiao Cheng
Attending surgeon, division of colon and rectal surgery
Tri-Service General Hospital