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

Study Overview
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Brief Summary
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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.

Official Title
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The Optimal Timing of Botulinum Toxin Injection for Pain Control in Patients Undergoing Hemorrhoidectomy-A Prospective, Randomized Study

Conditions
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The Influence of Timing of Botulinum Toxin Injection on Postoperative Pain Control

Intervention / Treatment
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* Biological: botulinum toxin type A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Botulinum toxin injection during surgery<br>Patients in this group underwent Botulinum toxin injection during surgery | Biological: botulinum toxin type A<br>* In the outpatient department, patients who need hemorrhoidectomy 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.<br>* Other names: Botox;|
| Experimental: Botulinum toxin injection one week before surgery<br>Patients in this group underwent Botulinum toxin injection at the outpatient clinic one week before surgery | Biological: botulinum toxin type A<br>* In the outpatient department, patients who need hemorrhoidectomy 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.<br>* Other names: Botox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one week after operation | 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. | 1 weel | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemorrhoidectomy, botulinum toxin, pain, wound healing