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Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy (TAGASH)

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ClinicalTrials.gov Identifier: NCT01279551
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
University of Roma La Sapienza

Study Description
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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 Design
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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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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Postoperative pain remission [ Time Frame: from 1 to 90 days after intervention ]
    To assess postoperative pain remission

  3. 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 :
  1. 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

  2. Use of additional analgesic [ Time Frame: from 1 to 90 days to intervention ]
    To evaluate the use of additional drugs respect to standard therapy

  3. 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)

  4. Patients satisfaction [ Time Frame: 45 days after intervention ]
    To evaluate the satisfaction of the patients, assessed by a questionnaire (scale from 1 to 5)


Eligibility Criteria
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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)
Contacts and Locations
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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
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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
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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