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
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Sponsor:
University of Roma La Sapienza
Information provided by:
University of Roma La Sapienza
Tracking Information | |||||||
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First Submitted Date ICMJE | January 18, 2011 | ||||||
First Posted Date ICMJE | January 19, 2011 | ||||||
Last Update Posted Date | January 25, 2011 | ||||||
Study Start Date ICMJE | January 2004 | ||||||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT01279551 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy | ||||||
Official Title ICMJE | Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Pain After Stapled Haemorrhoidopexy | ||||||
Intervention ICMJE |
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Study Arms |
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Publications * | 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
40 | ||||||
Original Actual Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date | December 2010 | ||||||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Italy | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01279551 | ||||||
Other Study ID Numbers ICMJE | DS-003 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Not Provided | ||||||
Study Sponsor ICMJE | University of Roma La Sapienza | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | University of Roma La Sapienza | ||||||
Verification Date | January 2011 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |