Reduction of Postoperative Pain After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

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A prospective ranfomized clinical study of patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain) will be performed. The patients will be randomized into 2 groups:

* Experimental group (EG): Patients undergoing Milligan Morgan´s procedure and application of Vitamin E ointment on the surgical bed.
* Control group (CG): Patients undergoing Milligan Morgan´s procedure and application of Vaseline on the surgical bed.

Postoperative pain determined by VAS at the 1st, 3rd and 7th postoperative days, and need for morphine rescue will be investigated.

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Detailed Description

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A prospective ranfomized clinical study of patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain) will be performed. The patients will be randomized into 2 groups:

* Experimental group (EG): Patients undergoing Milligan Morgan´s procedure and application of Vitamin E ointment on the surgical bed.
* Control group (CG): Patients undergoing Milligan Morgan´s procedure and application of Vaseline on the surgical bed.

Postoperative pain determined by VAS at the 1st, 3rd and 7th postoperative days, and need for morphine rescue will be investigated by a blined epidemiology nurse.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vitamin E ointment

Vitamin E ointment application. Every 12 hours during 7 days.

Group Type EXPERIMENTAL

Vitamin E ointment application

Intervention Type DRUG

Vitamin E ointment application. Every 12 hours during 7 days.

Vaseline ointment

Vaseline ointment application. Every 12 hours during 7 days.

Group Type PLACEBO_COMPARATOR

Vaseline ointment application

Intervention Type DRUG

Vaseline ointment application. Every 12 hours during 7 days.

Interventions

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Vitamin E ointment application

Vitamin E ointment application. Every 12 hours during 7 days.

Intervention Type DRUG

Vaseline ointment application

Vaseline ointment application. Every 12 hours during 7 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain).
* Haemorrhoids grade III and IV
* The patients sign an Informed Consent Form agreeing their participation in the study.

Exclusion Criteria

* Patients undergoing other surgical techniques for haemorrhoidectomy, different tan Milligan Morgan
* Haemorrhoids grade I and II
* Patients with medical or surgical pathologies that do not allow the participation in the study
* Disability to understand and accept the entry in the study

Eligible Sex

ALL

Accepts Healthy Volunteers

No