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

University of Roma La Sapienza

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pain After Stapled Haemorrhoidopexy

Treatments: Drug: 0.4% nitroglycerin ointment; Drug: lidocaine cloridrato 2.5% ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT01279551

DS-003

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

GTN

Experimental group

Description:

In this arm the investigators administer local application of 0.4% nitroglycerin ointment and ketorolac tromethamine 10 mg

Treatment:

Drug: 0.4% nitroglycerin ointment

Control

Active Comparator group

Description:

In this arm the investigators administer local application of lidocaine cloridrato 2.5% and ketorolac tromethamine 10 mg.

Treatment:

Drug: lidocaine cloridrato 2.5% ointment