Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GTN | Experimental | In this arm the investigators administer local application of 0.4% nitroglycerin ointment and ketorolac tromethamine 10 mg |
|
| Control | Active Comparator | In this arm the investigators administer local application of lidocaine cloridrato 2.5% and ketorolac tromethamine 10 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.4% nitroglycerin ointment | Drug | Local endoanal application 2 times a day |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francesco Saverio Mari, MD | Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome | Principal Investigator |
| Luigi Masoni, MD | Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome | Rome | 00189 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23652752 | Derived | Mari FS, Nigri G, Dall'Oglio A, Cosenza UM, Milillo A, Terrenato I, Pancaldi A, Brescia A. Topical glyceryl trinitrate ointment for pain related to anal hypertonia after stapled hemorrhoidopexy: a randomized controlled trial. Dis Colon Rectum. 2013 Jun;56(6):768-73. doi: 10.1097/DCR.0b013e31828b282c. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009824 | Ointments |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| lidocaine cloridrato 2.5% ointment | Drug | Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day |
|
|
| 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 |