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

This study has been completed.
Sponsor:
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01279551
First received: January 18, 2011
Last updated: January 24, 2011
Last verified: January 2011
History of Changes

January 18, 2011
January 24, 2011
January 2004
September 2010   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01279551 on ClinicalTrials.gov Archive Site
  • 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)
  • 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 patiens, assessed by a questionarie (scale from 1 to 5)
Not Provided
Not Provided
 
Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy
Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Pain After Stapled Haemorrhoidopexy
  • 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
  • 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
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.
 
Completed
40
December 2010
September 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01279551
DS-003
Not Provided
Not Provided
Not Provided
Not Provided
University of Roma La Sapienza
Not Provided
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
University of Roma La Sapienza
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP