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Stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of less postoperative pain compared with excisional surgery, however a still relevant percentage of postoperative bleedings and long-term hemorrhoid recurrence are reported. A new stapler device has been designed to overcome these drawbacks by modifying the stapled sutures and by increasing the space for mucosal resection in the case of the stapler.
This randomized controlled study was aimed to demonstrate whether the new EEA stapler Covidien was able to resect more quantity of prolapsed mucosa than the traditional PPH 01/03 Ethicol Endosurgery by measuring the surface of the resected specimen and to demonstrate if the modified stapled sutures can ensure better intraoperative hemostasis by measuring the number of overstitches required to get perfect hemostasis during the operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EEA group | Experimental | Group of patients with III degree hemorrhoids treated by EEA stapler |
|
| PPH group | Active Comparator | group of patients with III degree hemorrhoids treated by PPH stapler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stapled hemorrhoidopexy | Procedure | stapled hemorrhoidopexy will be performed using the EEA stapler Covidien |
|
| Measure | Description | Time Frame |
|---|---|---|
| quantity of anorectal mucosa resected using two different circular staplers | The surface (in cm2)of anorectal mucosa resected during stapled hemorrhoidopexy for III degree hemorrhoids, using two different circular staplers will be compared | 1 hour following the end of the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers | the number of hemostatic sutures required to get perfect hemostasis during stapled hemorrhoidopexy using 2 different staplers for III degree hemorrhoids | 1 hour after each operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Emergency and Organ transplantation | Bari | 70124 | Italy |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| stapled hemorrhoidopexy | Procedure | stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |