PainPhase 3NCT02554123
Reduction of Postoperative Pain After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment
A Phase 3 study testing Vitamin E ointment application and Vaseline ointment application in people with Pain, run by Hospital General Universitario Elche.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- Vitamin E ointment application and Vaseline ointment application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Being tested
- Vitamin E ointment application, Vaseline ointment application
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin E ointment applicationDrug
Vitamin E ointment application. Every 12 hours during 7 days.
Vaseline ointment applicationDrug
Vaseline ointment application. Every 12 hours during 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E ointment | Experimental | Vitamin E ointment application. Every 12 hours during 7 days. Receives: Drug: Vitamin E ointment application |
| Vaseline ointment | Placebo comparator | Vaseline ointment application. Every 12 hours during 7 days. Receives: Drug: Vaseline ointment application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain will be quantified with a VAS scale at the 1st, 3rd and 7th postoperative days
Measured: From the first to the 7th postoperative days
Secondary outcomes (1)
Need for morphine rescue
Need for morphine rescue will be quantified in the first 24 hours after surgery during the hospital stay
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
- Investigators
- Manuel Duran, MD, PhD, Study director, Hospital Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554123
- Sponsor's protocol ID
- HRJC15-22
- Status last verified
- Sep 2015
- First submitted
- 17 Sep 2015
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Postoperative Pain and Improvement of Patients´Comfort After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment
- ClinicalTrials.gov ID
- NCT02554123
- Acronym / sponsor ID
- HRJC15-22
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin E ointment | Experimental | Drug: Vitamin E ointment applicationVitamin E ointment application. Every 12 hours during 7 days. |
| Vaseline ointment | Placebo comparator | Drug: Vaseline ointment applicationVaseline ointment application. Every 12 hours during 7 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin E ointment applicationVitamin E ointment application. Every 12 hours during 7 days. | Drug | Vitamin E ointment |
| Vaseline ointment applicationVaseline ointment application. Every 12 hours during 7 days. | Drug | Vaseline ointment |
Primary outcome
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
1 secondary outcome
Need for morphine rescue
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Duran, MD, PhD study director
Hospital Rey Juan Carlos
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin E ointment application and Vaseline ointment application in people with Pain, run by Hospital General Universitario Elche.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: From the first to the 7th postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.