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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04485780

Enrollment

Registered

2020-07-24

Start date

2018-10-08

Completion date

2021-12-31

Last updated

2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

hemorrhoidectomy, botulinum toxin, pain, wound healing

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.

Interventions

BIOLOGICALbotulinum toxin type A

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Taiwan

Contacts

Primary ContactYi-Chiao Cheng

ndmcjoe@gmail.com+886912959022

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026