Pain After Stapled Haemorrhoidopexy
Conditions
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.
Interventions
DRUG0.4% nitroglycerin ointment
Local endoanal application 2 times a day
DRUGlidocaine cloridrato 2.5% ointment
Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of therapy | from 1 to 90 days after intervention | To evaluate how many days of therapy are needed to obtain pain remission |
| Patients satisfaction | 45 days after intervention | To evaluate the satisfaction of the patients, assessed by a questionnaire (scale from 1 to 5) |
| 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) |
Countries
Italy
Outcome results
None listed