Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07399860
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥18 years, male and female
* Symptomatic grade III-IV hemorrhoidal disease (Goligher), refractory to conservative treatment
* Scheduled for open (Milligan-Morgan) or closed (Ferguson) hemorrhoidectomy
Exclusion Criteria:
* Known hypersensitivity to botulinum toxin A, human albumin, or local anesthetics.
* Neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome).
* Use of aminoglycosides or other agents interfering with neuromuscular transmission within 14 days.
* Coagulopathy or ongoing anticoagulant therapy not suitable for perioperative interruption.
* Active anorectal infection, fissure, abscess, or inflammatory bowel disease in the active phase.
* Previous anal sphincter surgery or baseline fecal incontinence.
* Pregnancy or breastfeeding.
* ASA ≥ III or significant systemic disease compromising anesthesia or wound healing.
* Participation in another interventional clinical trial within 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07399860
Study Brief:
Protocol Section:
NCT07399860