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

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
botulinum toxin type A
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for The Influence of Timing of Botulinum Toxin Injection on Postoperative Pain Control focused on measuring hemorrhoidectomy, botulinum toxin, pain, wound healing

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tri-Service General Hospital, National Defense Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Botulinum toxin injection during surgery

Botulinum toxin injection one week before surgery

Arm Description

Patients in this group underwent Botulinum toxin injection during surgery

Patients in this group underwent Botulinum toxin injection at the outpatient clinic one week before surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 21, 2020
Last Updated
July 21, 2020
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04485780
Brief Title
Botulinum Toxin Injection in Patients Undergoing Hemorrhoidectomy-A Prospective, Randomized Study
Official Title
The Optimal Timing of Botulinum Toxin Injection for Pain Control in Patients Undergoing Hemorrhoidectomy-A Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Influence of Timing of Botulinum Toxin Injection on Postoperative Pain Control
Keywords
hemorrhoidectomy, botulinum toxin, pain, wound healing

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin injection during surgery
Arm Type
Placebo Comparator
Arm Description
Patients in this group underwent Botulinum toxin injection during surgery
Arm Title
Botulinum toxin injection one week before surgery
Arm Type
Experimental
Arm Description
Patients in this group underwent Botulinum toxin injection at the outpatient clinic one week before surgery
Intervention Type
Biological
Intervention Name(s)
botulinum toxin type A
Other Intervention Name(s)
Botox
Intervention Description
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.
Primary Outcome Measure Information:
Title
one week after operation
Description
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.
Time Frame
1 weel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Chiao Cheng
Phone
+886912959022
Email
ndmcjoe@gmail.com
Facility Information:
Facility Name
Tri-Service General Hospital, National Defense Medical Center
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Chiao Cheng
Phone
+886912959022
Email
ndmcjoe@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
34705137
Citation
Cheng YC, Beh JY, Wu PH, Tsai NY, Jao SW. Early botulinum toxin injection reduces pain after hemorrhoidectomy: a pilot study. Tech Coloproctol. 2022 Jan;26(1):53-60. doi: 10.1007/s10151-021-02542-4. Epub 2021 Oct 27.
Results Reference
derived

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

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