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

NCT ID: NCT01279551

Last Updated: 2011-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain After Stapled Haemorrhoidopexy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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GTN

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

Group Type EXPERIMENTAL

0.4% nitroglycerin ointment

Intervention Type DRUG

Local endoanal application 2 times a day

Control

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

Group Type ACTIVE_COMPARATOR

lidocaine cloridrato 2.5% ointment

Intervention Type DRUG

Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day

Interventions

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0.4% nitroglycerin ointment

Local endoanal application 2 times a day

Intervention Type DRUG

lidocaine cloridrato 2.5% ointment

Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day

Intervention Type DRUG

Other Intervention Names

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Rectogesic Luan

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Principal Investigators

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Francesco Saverio Mari, MD

Role: PRINCIPAL_INVESTIGATOR

Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome

Luigi Masoni, MD

Role: STUDY_CHAIR

Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome

Locations

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Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome

Rome, , Italy

Site Status

Countries

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Italy

References

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Mari FS, Nigri G, Dall'Oglio A, Cosenza UM, Milillo A, Terrenato I, Pancaldi A, Brescia A. Topical glyceryl trinitrate ointment for pain related to anal hypertonia after stapled hemorrhoidopexy: a randomized controlled trial. Dis Colon Rectum. 2013 Jun;56(6):768-73. doi: 10.1097/DCR.0b013e31828b282c.

Reference Type DERIVED
PMID: 23652752 (View on PubMed)

Other Identifiers

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DS-003

Identifier Type: -

Identifier Source: org_study_id

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