Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy

Resource links provided by NLM:

Drug Information available for: Nitroglycerin Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To assess postoperative pain remission
Postoperative anal resting pressure at pain remission [ Time Frame: from 1 to 90 days after intervention ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To evaluate the use of additional drugs respect to standard therapy
Postoperative pain intensity [ Time Frame: from 1 to 90 days after intervention ] [ Designated as safety issue: No ]
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)
Genders Eligible for Study:	Both
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

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):

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
Study First Received:	January 18, 2011
Last Updated:	January 24, 2011
Health Authority:	Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on September 27, 2016

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