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

Tri-Service General Hospital

Status and phase: Unknown; Phase 4

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

Treatments: Biological: botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT04485780

1-107-05-042

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups, including a placebo group

Botulinum toxin injection during surgery

Placebo Comparator group

Description:

Patients in this group underwent Botulinum toxin injection during surgery

Treatment:

Biological: botulinum toxin type A

Botulinum toxin injection one week before surgery

Experimental group

Description:

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

Treatment:

Biological: botulinum toxin type A