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

September 17, 2015 updated by: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Reduction of Postoperative Pain and Improvement of Patients´Comfort After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin E ointment
Vitamin E ointment application. Every 12 hours during 7 days.
Drug: Vitamin E ointment application
Vitamin E ointment application. Every 12 hours during 7 days.
Placebo Comparator: Vaseline ointment
Vaseline ointment application. Every 12 hours during 7 days.
Drug: Vaseline ointment application
Vaseline ointment application. Every 12 hours during 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: From the first to the 7th postoperative days
Postoperative pain will be quantified with a VAS scale at the 1st, 3rd and 7th postoperative days
From the first to the 7th postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for morphine rescue
Time Frame: 24 hours after surgery
Need for morphine rescue will be quantified in the first 24 hours after surgery during the hospital stay
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Elche

Investigators

  • Study Director: Manuel Duran, MD, PhD, Hospital Rey Juan Carlos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Estimate)

September 18, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRJC15-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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