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

Phase 2

Completed

• Conditions: Pain After Stapled Haemorrhoidopexy
• Interventions: Drug: 0.4% nitroglycerin ointment; Drug: lidocaine cloridrato 2.5% ointment

• Registration Number: NCT01279551
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2010-09
• Study Completion: 2010-12
• Status Verified: 2011-01
• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GTN	0.4% nitroglycerin ointment	In this arm the investigators administer local application of 0.4% nitroglycerin ointment and ketorolac tromethamine 10 mg
Control	lidocaine cloridrato 2.5% ointment	In this arm the investigators administer local application of lidocaine cloridrato 2.5% and ketorolac tromethamine 10 mg.

Primary Outcome Measures

Name	Time	Method
Postoperative pain related to upper anal canal pressure increasing (yes or no)	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
Postoperative pain remission	from 1 to 90 days after intervention	To assess postoperative pain remission
Postoperative anal resting pressure at pain remission	from 1 to 90 days after intervention	We evaluate with anorectal manometry the anal resting pressure at the time of pain remission

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome; 🇮🇹 Rome, Italy