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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Societa Italiana di Chirurgia ColoRettale
ClinicalTrials.gov Identifier:
NCT01413867
First received: August 8, 2011
Last updated: August 9, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
III Degree Hemorrhoids
 Procedure: stapled hemorrhoidopexy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

Further study details as provided by Societa Italiana di Chirurgia ColoRettale:

Primary Outcome Measures:
  • quantity of anorectal mucosa resected using two different circular staplers [ Time Frame: 1 hour following the end of the operation ] [ Designated as safety issue: No ]
    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:
  • Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers [ Time Frame: 1 hour after each operation ] [ Designated as safety issue: Yes ]
    the number of hemostatic sutures required to get perfect hemostasis during stapled hemorrhoidopexy using 2 different staplers for III degree hemorrhoids


Enrollment: 120
Study Start Date: March 2011
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413867

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

No publications provided

Responsible Party: Donato F Altomare, MD, Associate professor of Surgery, Dept of Emergency and Organ transplantation, University of Bari, Bari, italy
ClinicalTrials.gov Identifier: NCT01413867     History of Changes
Other Study ID Numbers: No sponsor
Study First Received: August 8, 2011
Last Updated: August 9, 2011
Health Authority: Italy: Ethics Committee of the Azienda Ospedaliero-Universitaria Policlinico "Vittorio Emanuele"Catania, Italy

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013