Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02554123
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : September 18, 2015
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pain Drug: Vitamin E ointment application Drug: Vaseline ointment application Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reduction of Postoperative Pain and Improvement of Patients´Comfort After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment
Study Start Date : January 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554123


Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
Layout table for investigator information
Study Director: Manuel Duran, MD, PhD Hospital Rey Juan Carlos

Layout table for additonal information
Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Professor of Surgery, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT02554123     History of Changes
Other Study ID Numbers: HRJC15-22
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Vitamins
Petrolatum
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Emollients
Dermatologic Agents