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

Study Overview
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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.

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

Conditions
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Pain After Stapled Haemorrhoidopexy

Intervention / Treatment
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* Drug: 0.4% nitroglycerin ointment
* Drug: lidocaine cloridrato 2.5% ointment


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain related to upper anal canal pressure increasing (yes or no) | 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 | To assess postoperative pain remission | from 1 to 90 days after intervention | 
| Postoperative anal resting pressure at pain remission | 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 | To evaluate how many days of therapy are needed to obtain pain remission | from 1 to 90 days after intervention | 
| Use of additional analgesic | To evaluate the use of additional drugs respect to standard therapy | from 1 to 90 days to intervention | 
| Postoperative pain intensity | To evaluate the intensity of postoperative pain assessed by VAS (visual analogue scale) | from 1 to 90 days after intervention | 
| Patients satisfaction | To evaluate the satisfaction of the patients, assessed by a questionnaire (scale from 1 to 5) | 45 days after intervention |