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Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy (TAGASH)
This study has been completed.
Sponsor:
University of Roma La Sapienza
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01279551
First received: January 18, 2011
Last updated: January 24, 2011
Last verified: January 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Pain After Stapled Haemorrhoidopexy | Drug: 0.4% nitroglycerin ointment Drug: lidocaine cloridrato 2.5% ointment | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment |
| Official Title: | Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy |
Resource links provided by NLM:
Further study details as provided by University of Roma La Sapienza:
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)
| Enrollment: | 40 |
| Study Start Date: | January 2004 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: GTN
In this arm the investigators administer local application of 0.4% nitroglycerin ointment and ketorolac tromethamine 10 mg
|
Drug: 0.4% nitroglycerin ointment
Local endoanal application 2 times a day
Other Name: Rectogesic
|
|
Active Comparator: Control
In this arm the investigators administer local application of lidocaine cloridrato 2.5% and ketorolac tromethamine 10 mg.
|
Drug: lidocaine cloridrato 2.5% ointment
Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day
Other Name: Luan
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| 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)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01279551
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
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 |
| Study First Received: | January 18, 2011 |
| Last Updated: | January 24, 2011 |
Additional relevant MeSH terms:
|
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 Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Vasodilator Agents |
ClinicalTrials.gov processed this record on June 28, 2017