Pain Relief for Thrombosed External Haemorrhoids

NCT00717782 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2008-07-18

No results posted yet for this study

Summary

Thrombosed external haemorrhoids are one of the most frequent anorectal emergencies. They are associated with swelling and intense pain. This study evaluated the efficacy and safety of an intersphincteric injection of botulinum toxin for pain relief in patients with thrombosed external haemorrhoids

Conditions

  • Thrombosed External Hemorrhoid

Interventions

PROCEDURE

injection of botulinum toxin

Patients received a 0·6-ml injection of a solution containing 30 units botulinum toxin into the internal anal sphincter

PROCEDURE

injection of saline

Patients received a 0·6-ml injection of a saline solution into the internal anal sphincter

Sponsors & Collaborators

  • University of Palermo

    lead OTHER

Principal Investigators

  • Gaetano Di Vita · A.O.U.P.

  • Rosalia Patti · A.O.U.P.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2005-12-31
Completion
2006-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00717782 on ClinicalTrials.gov