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

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

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, 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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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mari FS, Nigri G, Dall'Oglio A, Cosenza UM, Milillo A, Terrenato I, Pancaldi A, Brescia A. Topical glyceryl trinitrate ointment for pain related to anal hypertonia after stapled hemorrhoidopexy: a randomized controlled trial. Dis Colon Rectum. 2013 Jun;56(6):768-73. doi: 10.1097/DCR.0b013e31828b282c.

ClinicalTrials.gov Identifier:	NCT01279551 History of Changes
Other Study ID Numbers:	DS-003
First Posted:	January 19, 2011
Last Update Posted:	January 25, 2011
Last Verified:	January 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; Vasodilator Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors