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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 therapy

Use 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

Page last updated: August 23, 2015

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