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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
  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:

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by University of Roma La Sapienza

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

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

ClinicalTrials.gov processed this record on March 01, 2015