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

Tracking Information
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; (submitted: January 18, 2011)	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
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; (submitted: January 24, 2011)	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)
Original Secondary Outcome Measures ICMJE; (submitted: January 18, 2011)	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 patiens, assessed by a questionarie (scale from 1 to 5)
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
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition ICMJE	Pain After Stapled Haemorrhoidopexy
Intervention ICMJE	Drug: 0.4% nitroglycerin ointment Local endoanal application 2 times a day Other Name: Rectogesic; Drug: lidocaine cloridrato 2.5% ointment Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day Other Name: Luan
Study Arms	Experimental: GTN In this arm the investigators administer local application of 0.4% nitroglycerin ointment and ketorolac tromethamine 10 mg Intervention: Drug: 0.4% nitroglycerin ointment; Active Comparator: Control In this arm the investigators administer local application of lidocaine cloridrato 2.5% and ketorolac tromethamine 10 mg. Intervention: Drug: lidocaine cloridrato 2.5% ointment
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 18, 2011)	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: 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)
Sex/Gender	Sexes Eligible for Study: All
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	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
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