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

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Vitamin E ointment application; Drug: Vaseline ointment application

• Registration Number: NCT02554123
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-01
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-17
• Last Update Submitted: 2015-09-17
• Study First Posted: 2015-09-18
• Last Update Posted: 2015-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin E ointment	Vitamin E ointment application	Vitamin E ointment application. Every 12 hours during 7 days.
Vaseline ointment	Vaseline ointment application	Vaseline ointment application. Every 12 hours during 7 days.

Primary Outcome Measures

Name	Time	Method
Postoperative pain	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

Name	Time	Method
Need for morphine rescue	24 hours after surgery	Need for morphine rescue will be quantified in the first 24 hours after surgery during the hospital stay