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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):
Donato F Altomare, Societa Italiana di Chirurgia ColoRettale

August 8, 2011
August 10, 2011
December 11, 2013
March 2011
December 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01413867 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Safety and Short Term Effectiveness of EEA Versus PPH Stapler for III Degree Hemorrhoids
Safety and Short Term Effectiveness of EEA Stapler vs PPH Stapler in the Treatment of III Degree Haemorrhoids. Prospective Randomized Controlled Trial

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
III Degree Hemorrhoids
  • Procedure: stapled hemorrhoidopexy
    stapled hemorrhoidopexy will be performed using the EEA stapler Covidien
  • Procedure: stapled hemorrhoidopexy
    stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery
  • Experimental: EEA group
    Group of patients with III degree hemorrhoids treated by EEA stapler
    Intervention: Procedure: stapled hemorrhoidopexy
  • Active Comparator: PPH group
    group of patients with III degree hemorrhoids treated by PPH stapler
    Intervention: Procedure: stapled hemorrhoidopexy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
Same as current
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01413867
No sponsor
No
Not Provided
Not Provided
Donato F Altomare, Societa Italiana di Chirurgia ColoRettale
Societa Italiana di Chirurgia ColoRettale
Not Provided
Not Provided
Societa Italiana di Chirurgia ColoRettale
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP