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

NCT ID: NCT01413867

Last Updated: 2013-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-12-31

Brief Summary

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.

Conditions

III Degree Hemorrhoids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EEA group

Group of patients with III degree hemorrhoids treated by EEA stapler

Group Type: EXPERIMENTAL

stapled hemorrhoidopexy

Intervention Type: PROCEDURE

stapled hemorrhoidopexy will be performed using the EEA stapler Covidien

PPH group

group of patients with III degree hemorrhoids treated by PPH stapler

Group Type: ACTIVE_COMPARATOR

stapled hemorrhoidopexy

Intervention Type: PROCEDURE

stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery

Interventions

stapled hemorrhoidopexy

stapled hemorrhoidopexy will be performed using the EEA stapler Covidien

Intervention Type: PROCEDURE

stapled hemorrhoidopexy

stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Societa Italiana di Chirurgia ColoRettale

NETWORK

Sponsor Role: lead

Responsible Party

Donato F Altomare

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dept of Emergency and Organ transplantation

Bari, , Italy

Countries

Italy

Other Identifiers

No sponsor

Identifier Type: -

Identifier Source: org_study_id