Reduction of Postoperative Pain After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pain
Started Jan 2015
Shorter than P25 for phase_3 pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 17, 2015
CompletedFirst Posted
Study publicly available on registry
September 18, 2015
CompletedSeptember 18, 2015
September 1, 2015
8 months
September 17, 2015
September 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pain
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 Outcomes (1)
Need for morphine rescue
24 hours after surgery
Study Arms (2)
Vitamin E ointment
EXPERIMENTALVitamin E ointment application. Every 12 hours during 7 days.
Vaseline ointment
PLACEBO COMPARATORVaseline ointment application. Every 12 hours during 7 days.
Interventions
Vitamin E ointment application. Every 12 hours during 7 days.
Vaseline ointment application. Every 12 hours during 7 days.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Manuel Duran, MD, PhD
Hospital Rey Juan Carlos
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery
Study Record Dates
First Submitted
September 17, 2015
First Posted
September 18, 2015
Study Start
January 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
September 18, 2015
Record last verified: 2015-09