Safety and Short Term Effectiveness of EEA Versus PPH Stapler for III Degree Hemorrhoids

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Short Term Effectiveness of EEA Stapler vs PPH Stapler in the Treatment of III Degree Haemorrhoids. Prospective Randomized Controlled Trial

Conditions
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III Degree Hemorrhoids

Intervention / Treatment
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* Procedure: stapled hemorrhoidopexy
* Procedure: stapled hemorrhoidopexy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: III degree Hemorrhoids written informed consent mental ability to understand the procedure Exclusion Criteria: Previous treatments for hemorrhoids or other proctological diseases Fecal Incontinence Chronic inflammatory bowel disease Anal sphincter lesions coagulative defects obstructed defecation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EEA group<br>Group of patients with III degree hemorrhoids treated by EEA stapler | Procedure: stapled hemorrhoidopexy<br>* stapled hemorrhoidopexy will be performed using the EEA stapler Covidien<br>|
| Active Comparator: PPH group<br>group of patients with III degree hemorrhoids treated by PPH stapler | Procedure: stapled hemorrhoidopexy<br>* stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemorrhoids, circular staplers, mucosal resection, hemostatic suture