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

January 24, 2011 updated by: University of Roma La Sapienza
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00189
        • Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GTN
In this arm the investigators administer local application of 0.4% nitroglycerin ointment and ketorolac tromethamine 10 mg
Drug: 0.4% nitroglycerin ointment
Local endoanal application 2 times a day
Other Names:
  • Rectogesic
Active Comparator: Control
In this arm the investigators administer local application of lidocaine cloridrato 2.5% and ketorolac tromethamine 10 mg.
Drug: lidocaine cloridrato 2.5% ointment
Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day
Other Names:
  • Luan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain related to upper anal canal pressure increasing (yes or no)
Time Frame: from the intervention to 1 month
To evaluate if the pain post stapled haemorrhoidopexy is related to an increased anal resting pressure or not. The presence of anorectal spasm was assessed by clinical examination and anorectal manometry
from the intervention to 1 month
Postoperative pain remission
Time Frame: from 1 to 90 days after intervention
To assess postoperative pain remission
from 1 to 90 days after intervention
Postoperative anal resting pressure at pain remission
Time Frame: from 1 to 90 days after intervention
We evaluate with anorectal manometry the anal resting pressure at the time of pain remission
from 1 to 90 days after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of therapy
Time Frame: from 1 to 90 days after intervention
To evaluate how many days of therapy are needed to obtain pain remission
from 1 to 90 days after intervention
Use of additional analgesic
Time Frame: from 1 to 90 days to intervention
To evaluate the use of additional drugs respect to standard therapy
from 1 to 90 days to intervention
Postoperative pain intensity
Time Frame: from 1 to 90 days after intervention
To evaluate the intensity of postoperative pain assessed by VAS (visual analogue scale)
from 1 to 90 days after intervention
Patients satisfaction
Time Frame: 45 days after intervention
To evaluate the satisfaction of the patients, assessed by a questionnaire (scale from 1 to 5)
45 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Principal Investigator: Francesco Saverio Mari, MD, Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome
  • Study Chair: Luigi Masoni, MD, Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 18, 2011

First Submitted That Met QC Criteria

January 18, 2011

First Posted (Estimate)

January 19, 2011

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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