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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-08

Study Completion Date

2021-12-31

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Botulinum toxin injection during surgery

Patients in this group underwent Botulinum toxin injection during surgery

Group Type PLACEBO_COMPARATOR

botulinum toxin type A

Intervention Type BIOLOGICAL

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.

Botulinum toxin injection one week before surgery

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

Group Type EXPERIMENTAL

botulinum toxin type A

Intervention Type BIOLOGICAL

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.

Interventions

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botulinum 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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Botox

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes