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

Pain After Stapled Haemorrhoidopexy Clinical Trial

— TAGASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279551
• Other study ID #: DS-003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 18, 2011
• Last updated: January 24, 2011
• Start date: January 2004
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain After Stapled Haemorrhoidopexy

Intervention

Drug:
• 0.4% nitroglycerin ointment
Local endoanal application 2 times a day
• lidocaine cloridrato 2.5% ointment
Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day

Locations

Country	Name	City	State
Italy	Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Postoperative pain remission	To assess postoperative pain remission	from 1 to 90 days after intervention	No
Primary	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	No
Secondary	Duration of therapy	To evaluate how many days of therapy are needed to obtain pain remission	from 1 to 90 days after intervention	No
Secondary	Use of additional analgesic	To evaluate the use of additional drugs respect to standard therapy	from 1 to 90 days to intervention	No
Secondary	Postoperative pain intensity	To evaluate the intensity of postoperative pain assessed by VAS (visual analogue scale)	from 1 to 90 days after intervention	No
Secondary	Patients satisfaction	To evaluate the satisfaction of the patients, assessed by a questionnaire (scale from 1 to 5)	45 days after intervention