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

Overview

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.

Full Title of Study: “Reduction of Postoperative Pain and Improvement of Patients´Comfort After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 2015

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.

Interventions

  • Drug: Vitamin E ointment application
    • Vitamin E ointment application. Every 12 hours during 7 days.
  • Drug: Vaseline ointment application
    • Vaseline ointment application. Every 12 hours during 7 days.

Arms, Groups and Cohorts

  • Experimental: Vitamin E ointment
    • Vitamin E ointment application. Every 12 hours during 7 days.
  • Placebo Comparator: Vaseline ointment
    • Vaseline ointment application. Every 12 hours during 7 days.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital General Universitario Elche
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jaime Ruiz-Tovar, MD, PhD, Professor of Surgery – Hospital General Universitario Elche
  • Overall Official(s)
    • Manuel Duran, MD, PhD, Study Director, Hospital Rey Juan Carlos

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