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

Sponsor
University of Roma La Sapienza (Other)
Overall Status
Completed
CT.gov ID
NCT01279551
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
83
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.4% nitroglycerin ointment
  • Drug: lidocaine cloridrato 2.5% ointment
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Luan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative pain related to upper anal canal pressure increasing (yes or no) [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

    2. Postoperative pain remission [from 1 to 90 days after intervention]

      To assess postoperative pain remission

    3. Postoperative anal resting pressure at pain remission [from 1 to 90 days after intervention]

      We evaluate with anorectal manometry the anal resting pressure at the time of pain remission

    Secondary Outcome Measures

    1. Duration of therapy [from 1 to 90 days after intervention]

      To evaluate how many days of therapy are needed to obtain pain remission

    2. Use of additional analgesic [from 1 to 90 days to intervention]

      To evaluate the use of additional drugs respect to standard therapy

    3. Postoperative pain intensity [from 1 to 90 days after intervention]

      To evaluate the intensity of postoperative pain assessed by VAS (visual analogue scale)

    4. Patients satisfaction [45 days after intervention]

      To evaluate the satisfaction of the patients, assessed by a questionnaire (scale from 1 to 5)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01279551
    Other Study ID Numbers:
    • DS-003
    First Posted:
    Jan 19, 2011
    Last Update Posted:
    Jan 25, 2011
    Last Verified:
    Jan 1, 2011
    Additional relevant MeSH terms:
    Lidocaine
    Nitroglycerin

    Study Results

    No Results Posted as of Jan 25, 2011