Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy (TAGASH)
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| ClinicalTrials.gov Identifier: NCT01279551 |
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Recruitment Status :
Completed
First Posted : January 19, 2011
Last Update Posted : January 25, 2011
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Sponsor:
University of Roma La Sapienza
Information provided by:
University of Roma La Sapienza
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain After Stapled Haemorrhoidopexy | Drug: 0.4% nitroglycerin ointment Drug: lidocaine cloridrato 2.5% ointment | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy |
| Study Start Date : | January 2004 |
| Actual Primary Completion Date : | September 2010 |
| Actual Study Completion Date : | December 2010 |
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| Arm | Intervention/treatment |
|---|---|
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Experimental: GTN
In this arm the investigators administer local application of 0.4% nitroglycerin ointment and ketorolac tromethamine 10 mg
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Drug: 0.4% nitroglycerin ointment
Local endoanal application 2 times a day
Other Name: Rectogesic |
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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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Drug: lidocaine cloridrato 2.5% ointment
Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day
Other Name: Luan |
Primary Outcome Measures :
- Postoperative pain related to upper anal canal pressure increasing (yes or no) [ Time Frame: from the intervention to 1 month ]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
- Postoperative pain remission [ Time Frame: from 1 to 90 days after intervention ]To assess postoperative pain remission
- Postoperative anal resting pressure at pain remission [ Time Frame: from 1 to 90 days after intervention ]We evaluate with anorectal manometry the anal resting pressure at the time of pain remission
Secondary Outcome Measures :
- Duration of therapy [ Time Frame: from 1 to 90 days after intervention ]To evaluate how many days of therapy are needed to obtain pain remission
- Use of additional analgesic [ Time Frame: from 1 to 90 days to intervention ]To evaluate the use of additional drugs respect to standard therapy
- Postoperative pain intensity [ Time Frame: from 1 to 90 days after intervention ]To evaluate the intensity of postoperative pain assessed by VAS (visual analogue scale)
- Patients satisfaction [ Time Frame: 45 days after intervention ]To evaluate the satisfaction of the patients, assessed by a questionnaire (scale from 1 to 5)
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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)
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): NCT01279551
Locations
| Italy | |
| Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome | |
| Rome, Italy, 00189 | |
Sponsors and Collaborators
University of Roma La Sapienza
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT01279551 History of Changes |
| Other Study ID Numbers: |
DS-003 |
| First Posted: | January 19, 2011 Key Record Dates |
| Last Update Posted: | January 25, 2011 |
| Last Verified: | January 2011 |
Additional relevant MeSH terms:
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Lidocaine Ketorolac Tromethamine Nitroglycerin Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers |
Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasodilator Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors |