NCT04485780

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

3.2 years

First QC Date

July 21, 2020

Last Update Submit

July 21, 2020

Conditions

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

Keywords

hemorrhoidectomybotulinum toxinpainwound healing

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Botulinum toxin injection during surgery

PLACEBO COMPARATOR

Patients in this group underwent Botulinum toxin injection during surgery

Biological: botulinum toxin type A

Botulinum toxin injection one week before surgery

EXPERIMENTAL

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

Biological: botulinum toxin type A

Interventions

botulinum toxin type ABIOLOGICAL

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.

Also known as: Botox
Botulinum toxin injection during surgeryBotulinum toxin injection one week before surgery

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with age over 20 but under 80, who need to undergo hemorrhoidectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34705137DERIVED

MeSH Terms

Conditions

Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Central Study Contacts

Yi-Chiao Cheng

CONTACT

+886912959022ndmcjoe@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending surgeon, division of colon and rectal surgery

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 24, 2020

Study Start

October 8, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 24, 2020

Record last verified: 2020-07

Locations

TW(1)