Hemorrhoidectomy Clinical Trials

Clinical trials related to Hemorrhoidectomy Procedure

Effect of Internal Anal Sphincter Botulinum Toxin A Injection 7 Days Before Hemorrhoidectomy on Postoperative Pain: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Hemorrhoidectomy is an effective surgical treatment for advanced hemorrhoidal disease but is often associated with significant postoperative pain, which may delay recovery. One of the main contributors to pain after hemorrhoidectomy is spasm and increased tone of the internal anal sphincter. This randomized, double-blind, placebo-controlled clinical trial evaluates whether preoperative injection of botulinum toxin type A into the internal anal sphincter, performed seven days before hemorrhoidectomy, can reduce postoperative pain compared with placebo. Adult patients with grade III-IV hemorrhoids scheduled for excisional hemorrhoidectomy will be randomized to receive either botulinum toxin A or saline injection prior to surgery. Postoperative pain intensity, analgesic consumption, complications, functional outcomes, and patient satisfaction will be assessed during the first 30 days after surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Lomonosov Moscow State University Medical Research and Educational Center
RECRUITING
Moscow
Contact Information
Primary
Tatiana Garmanova, MD, PhD
tatianagarmanova@gmail.com
+ 7 977 342 92 49
Backup
Aleksandr Lukianov, MD
alexmaxl1225469@gmail.com
+ 7 916 772 93 03
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2028-01
Participants
Target number of participants: 292
Treatments
Experimental: Preoperative Botulinum Toxin A Injection
Participants receive a preoperative injection of botulinum toxin type A into the internal anal sphincter seven days prior to excisional hemorrhoidectomy, in addition to standard surgical treatment.
Placebo_comparator: Preoperative Placebo Injection
Participants receive a preoperative injection of normal saline into the internal anal sphincter seven days prior to excisional hemorrhoidectomy, in addition to standard surgical treatment.
Related Therapeutic Areas
Sponsors
Leads: Lomonosov Moscow State University Medical Research and Educational Center

This content was sourced from clinicaltrials.gov

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