Safety and Short Term Effectiveness of EEA Versus PPH Stapler for III Degree Hemorrhoids (EEA/PPH2011)

Societa Italiana di Chirurgia ColoRettale

Status and phase: Completed; Phase 3

Conditions: III Degree Hemorrhoids

Treatments: Procedure: stapled hemorrhoidopexy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01413867

No sponsor

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

EEA group

Experimental group

Description:

Group of patients with III degree hemorrhoids treated by EEA stapler

Treatment:

Procedure: stapled hemorrhoidopexy

Procedure: stapled hemorrhoidopexy

PPH group

Active Comparator group

Description:

group of patients with III degree hemorrhoids treated by PPH stapler

Treatment:

Procedure: stapled hemorrhoidopexy

Procedure: stapled hemorrhoidopexy