- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01279551
Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy (TAGASH)
January 24, 2011 updated by: University of Roma La Sapienza
This study wants demonstrate that the use of 0.4% nitroglycerin ointment can reduce the postoperative pain related to anorectal spasm (anismus) while performing a stapled haemorrhoidopexy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rome, Italy, 00189
- Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with symptomatic II-III grade haemorrhoids and rectal mucosal prolapse
- Adults aged ≤ 75, male or female
Exclusion Criteria:
- Concomitant ano-rectal disease (fissure, fistula, abscess, inflammatory bowel disease, rectal cancer)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GTN
In this arm the investigators administer local application of 0.4% nitroglycerin ointment and ketorolac tromethamine 10 mg
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Local endoanal application 2 times a day
Other Names:
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Active Comparator: Control
In this arm the investigators administer local application of lidocaine cloridrato 2.5% and ketorolac tromethamine 10 mg.
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Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain related to upper anal canal pressure increasing (yes or no)
Time Frame: from the intervention to 1 month
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To evaluate if the pain post stapled haemorrhoidopexy is related to an increased anal resting pressure or not.
The presence of anorectal spasm was assessed by clinical examination and anorectal manometry
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from the intervention to 1 month
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Postoperative pain remission
Time Frame: from 1 to 90 days after intervention
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To assess postoperative pain remission
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from 1 to 90 days after intervention
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Postoperative anal resting pressure at pain remission
Time Frame: from 1 to 90 days after intervention
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We evaluate with anorectal manometry the anal resting pressure at the time of pain remission
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from 1 to 90 days after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of therapy
Time Frame: from 1 to 90 days after intervention
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To evaluate how many days of therapy are needed to obtain pain remission
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from 1 to 90 days after intervention
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Use of additional analgesic
Time Frame: from 1 to 90 days to intervention
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To evaluate the use of additional drugs respect to standard therapy
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from 1 to 90 days to intervention
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Postoperative pain intensity
Time Frame: from 1 to 90 days after intervention
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To evaluate the intensity of postoperative pain assessed by VAS (visual analogue scale)
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from 1 to 90 days after intervention
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Patients satisfaction
Time Frame: 45 days after intervention
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To evaluate the satisfaction of the patients, assessed by a questionnaire (scale from 1 to 5)
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45 days after intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francesco Saverio Mari, MD, Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome
- Study Chair: Luigi Masoni, MD, Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
January 18, 2011
First Submitted That Met QC Criteria
January 18, 2011
First Posted (Estimate)
January 19, 2011
Study Record Updates
Last Update Posted (Estimate)
January 25, 2011
Last Update Submitted That Met QC Criteria
January 24, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Nitroglycerin
Other Study ID Numbers
- DS-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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