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The effect of intrasphincteric botox injection during hemorrhoidopexy with stapler on postoperative clinical outcomes of a double-blind clinical trial study

The effect of intrasphincteric botox injection during hemorrhoidopexy with stapler on postoperative clinical outcomes of a double-blind clinical trial study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130826014483N12
Enrollment
68
Registered
2025-06-25
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Hemorrhoidopexy. Third degree hemorrhoids

Interventions

Intervention 1: Intervention group: Botox solution manufactured by Masoon Darou Company from Iran in an amount of 0.4 ml as an injection at the site of the operation. Intervention 2: Control group: Pl

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age Patients with symptomatic grade 3 or 4 hemorrhoids who are indicated for hemorrhoidectomy

Exclusion criteria

Exclusion criteria: Patients with inflammatory bowel disease Patients with fistula disease, Previous history of surgery in the anal area Patients with dermatitis, proctitis Patients with pregnancy-related illness Cardiovascular diseases Patients with severe respiratory illness Patients with cleft palate

Design outcomes

Primary

MeasureTime frame
Pain intensity. Timepoint: It will be coded at 6 and 12 hours after surgery and again on days 1, 2, 7, and 14 after surgery. Pain will also be assessed after the first to fifth bowel movements. Method of measurement: Visual Analogue Scale.

Secondary

MeasureTime frame
Wound healing quality. Timepoint: After surgery, five check-ups will be performed every two weeks from day 30 to 4 months after surgery. Method of measurement: Information collection form.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMina Alvandipour

Mazandaran University of Medical Sciences

malvandipour@mazums.ac.ir+98 11 3336 1700

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: May 18, 2026