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Application of Vitamin E on Anal Fissure

Primary Purpose

Pain

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Vitamin E Acetate ointment
Glyceryl trinitrate ointment
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with diagnosis of chronic anal fissure

Exclusion Criteria:

  • patients with associated anal pathologies
  • intestinal inflammation disorders
  • immunosuppression
  • fissures secondary to underlying diseases (eg, AIDS, tuberculosis, or sexually transmitted diseases)
  • patients with a history of headaches, heart disease, or intolerance to nitrates
  • pregnant or lactating women
  • patients with closed angle glaucoma

Sites / Locations

  • Garcilaso Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitamin E acetate

Glyceryl trinitrate ointment

Arm Description

Commercially available plastic tubes containing vitamin E acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml of ointment (containing 1100% vitamin E), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

Outcomes

Primary Outcome Measures

Pain associated to anal fissure: Visual Analogic Scale
Pain will be evaluated after finishing the treatment, by a Visual Analogic Scale, ranging from 0 (absence of pain) to 100mm (unbearable pain)

Secondary Outcome Measures

Number of participants achieving the healing of the fissure
Healing, defined as evidence of fissure reepithelization

Full Information

First Posted
December 21, 2018
Last Updated
April 20, 2020
Sponsor
Hospital General Universitario Elche
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1. Study Identification

Unique Protocol Identification Number
NCT03787030
Brief Title
Application of Vitamin E on Anal Fissure
Official Title
Application of Vitamin E Acetate Ointment vs Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients were randomized into 2 groups: Vitamin E: Vitamin E ointment will be applied during 8 weeks Nitroglycerin: Nitroglycerin ointment will be applied during 8 weeks Healing rate of chronic anal fissure in patients receiving Nitroglycerin ointment and subjects patients receiving Vitamin E ointment were evaluated .
Detailed Description
Patients were randomly assigned to experimental and control groups: those patients receiving vitamin E ointment (Experimental Group - EG) and those receiving glyceryl trinitrate ointment (Control Group - CG). Treatments: Glyceryl trinitrate ointment (GTO): Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period. Vitamin E acetate ointment (VEA): Commercially available plastic tubes containing VitaminE acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml, applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period. Healing rate of chronic anal fissure was investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
A nurse blinded to the treatment applied will evaluate the healing of chronic anal fissure and quantify pain
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin E acetate
Arm Type
Experimental
Arm Description
Commercially available plastic tubes containing vitamin E acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml of ointment (containing 1100% vitamin E), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.
Arm Title
Glyceryl trinitrate ointment
Arm Type
Active Comparator
Arm Description
Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.
Intervention Type
Drug
Intervention Name(s)
Vitamin E Acetate ointment
Intervention Description
Application of 1 ml of ointment to the distal anal canal, every 12 hours for an 8-week period.
Intervention Type
Drug
Intervention Name(s)
Glyceryl trinitrate ointment
Intervention Description
Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.
Primary Outcome Measure Information:
Title
Pain associated to anal fissure: Visual Analogic Scale
Description
Pain will be evaluated after finishing the treatment, by a Visual Analogic Scale, ranging from 0 (absence of pain) to 100mm (unbearable pain)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of participants achieving the healing of the fissure
Description
Healing, defined as evidence of fissure reepithelization
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with diagnosis of chronic anal fissure Exclusion Criteria: patients with associated anal pathologies intestinal inflammation disorders immunosuppression fissures secondary to underlying diseases (eg, AIDS, tuberculosis, or sexually transmitted diseases) patients with a history of headaches, heart disease, or intolerance to nitrates pregnant or lactating women patients with closed angle glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina Llavero
Organizational Affiliation
Garcilaso Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Garcilaso Clinic
City
Madrid
ZIP/Postal Code
28010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
34803148
Citation
Ruiz-Tovar J, Llavero C. Perianal Application of Glyceryl Trinitrate Ointment Versus Tocopherol Acetate Ointment in the Treatment of Chronic Anal Fissure: A Randomized Clinical Trial. Dis Colon Rectum. 2022 Mar 1;65(3):406-412. doi: 10.1097/DCR.0000000000002120.
Results Reference
derived

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Application of Vitamin E on Anal Fissure

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