Application of Vitamin E on Anal Fissure

• ClinicalTrials.gov Identifier: NCT03787030
• Recruitment Status: Completed
• First Posted: December 26, 2018
• Last Update Posted: April 22, 2020
• Sponsor: Hospital General Universitario Elche
• Information provided by (Responsible Party): Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

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 .

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Vitamin E Acetate ointment; Drug: Glyceryl trinitrate ointment	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: A nurse blinded to the treatment applied will evaluate the healing of chronic anal fissure and quantify pain
• Primary Purpose: Treatment
• Official Title: Application of Vitamin E Acetate Ointment vs Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure
• Actual Study Start Date: December 21, 2018
• Actual Primary Completion Date: February 28, 2019
• Actual Study Completion Date: February 28, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vitamin E acetate; 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.	Drug: Vitamin E Acetate ointment; Application of 1 ml of ointment to the distal anal canal, every 12 hours for an 8-week period.
Active Comparator: Glyceryl trinitrate ointment; 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.	Drug: Glyceryl trinitrate ointment; Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.

Outcome Measures

Primary Outcome Measures :

1. Pain associated to anal fissure: Visual Analogic Scale [ Time Frame: 8 weeks ]
   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 :

1. Number of participants achieving the healing of the fissure [ Time Frame: 8 weeks ]
   Healing, defined as evidence of fissure reepithelization

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Spain

Garcilaso Clinic

Madrid, Spain, 28010

Sponsors and Collaborators

Hospital General Universitario Elche

Investigators

• Study Director: Carolina Llavero; Garcilaso Clinic

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Department of Surgery, Hospital General Universitario Elche
• ClinicalTrials.gov Identifier: NCT03787030
• Other Study ID Numbers: Garcia 2018-12
• First Posted: December 26, 2018
• Last Update Posted: April 22, 2020
• Last Verified: April 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Fissure in Ano; Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vitamin E; Tocopherols; alpha-Tocopherol; Nitroglycerin; Vitamins; Micronutrients; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Vasodilator Agents