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

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ClinicalTrials.gov Identifier: NCT01413867
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
III Degree Hemorrhoids Procedure: stapled hemorrhoidopexy Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Short Term Effectiveness of EEA Stapler vs PPH Stapler in the Treatment of III Degree Haemorrhoids. Prospective Randomized Controlled Trial
Study Start Date : March 2011
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: EEA group
Group of patients with III degree hemorrhoids treated by EEA stapler
Procedure: stapled hemorrhoidopexy
stapled hemorrhoidopexy will be performed using the EEA stapler Covidien
Active Comparator: PPH group
group of patients with III degree hemorrhoids treated by PPH stapler
Procedure: stapled hemorrhoidopexy
stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery


Outcome Measures

Primary Outcome Measures :
  1. quantity of anorectal mucosa resected using two different circular staplers [ Time Frame: 1 hour following the end of the operation ]
    The surface (in cm2)of anorectal mucosa resected during stapled hemorrhoidopexy for III degree hemorrhoids, using two different circular staplers will be compared


Secondary Outcome Measures :
  1. Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers [ Time Frame: 1 hour after each operation ]
    the number of hemostatic sutures required to get perfect hemostasis during stapled hemorrhoidopexy using 2 different staplers for III degree hemorrhoids


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413867


Locations
Italy
Dept of Emergency and Organ transplantation
Bari, Italy, 70124
Sponsors and Collaborators
Societa Italiana di Chirurgia ColoRettale
More Information

Responsible Party: Donato F Altomare, Associate professor, Societa Italiana di Chirurgia ColoRettale
ClinicalTrials.gov Identifier: NCT01413867     History of Changes
Other Study ID Numbers: No sponsor
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Keywords provided by Donato F Altomare, Societa Italiana di Chirurgia ColoRettale:
hemorrhoids
circular staplers
mucosal resection
hemostatic suture

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases