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

U

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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