Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy
Information source: University of Roma La Sapienza
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain After Stapled Haemorrhoidopexy
Intervention: 0.4% nitroglycerin ointment (Drug); lidocaine cloridrato 2.5% ointment (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: University of Roma La Sapienza Official(s) and/or principal investigator(s): Francesco Saverio Mari, MD, Principal Investigator, Affiliation: Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome Luigi Masoni, MD, Study Chair, Affiliation: Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome
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.
Clinical Details
Official title: Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Postoperative pain related to upper anal canal pressure increasing (yes or no)Postoperative pain remission Postoperative anal resting pressure at pain remission
Secondary outcome: Duration of therapyUse of additional analgesic Postoperative pain intensity Patients satisfaction
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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)
Locations and Contacts
Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome, Rome 00189, Italy
Additional Information
Starting date: January 2004
Last updated: January 24, 2011
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