Back to resultsSafety and Short Term Effectiveness of EEA Versus PPH Stapler for III Degree Hemorrhoids (EEA/PPH2011)
Primary Purpose
III Degree Hemorrhoids
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
stapled hemorrhoidopexy
stapled hemorrhoidopexy
Sponsored by
About this trial
This is an interventional treatment trial for III Degree Hemorrhoids focused on measuring hemorrhoids, circular staplers, mucosal resection, hemostatic suture
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
Sites / Locations
- Dept of Emergency and Organ transplantation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EEA group
PPH group
Arm Description
Group of patients with III degree hemorrhoids treated by EEA stapler
group of patients with III degree hemorrhoids treated by PPH stapler
Outcomes
Primary Outcome Measures
quantity of anorectal mucosa resected using two different circular staplers
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
the number of hemostatic sutures required to get perfect hemostasis during stapled hemorrhoidopexy using 2 different staplers for III degree hemorrhoids
Full Information
NCT ID
NCT01413867
First Posted
August 8, 2011
Last Updated
December 10, 2013
Sponsor
Societa Italiana di Chirurgia ColoRettale
1. Study Identification
Unique Protocol Identification Number
NCT01413867
Brief Title
Safety and Short Term Effectiveness of EEA Versus PPH Stapler for III Degree Hemorrhoids
Acronym
EEA/PPH2011
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Societa Italiana di Chirurgia ColoRettale
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
III Degree Hemorrhoids
Keywords
hemorrhoids, circular staplers, mucosal resection, hemostatic suture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EEA group
Arm Type
Experimental
Arm Description
Group of patients with III degree hemorrhoids treated by EEA stapler
Arm Title
PPH group
Arm Type
Active Comparator
Arm Description
group of patients with III degree hemorrhoids treated by PPH stapler
Intervention Type
Procedure
Intervention Name(s)
stapled hemorrhoidopexy
Intervention Description
stapled hemorrhoidopexy will be performed using the EEA stapler Covidien
Intervention Type
Procedure
Intervention Name(s)
stapled hemorrhoidopexy
Intervention Description
stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery
Primary Outcome Measure Information:
Title
quantity of anorectal mucosa resected using two different circular staplers
Description
The surface (in cm2)of anorectal mucosa resected during stapled hemorrhoidopexy for III degree hemorrhoids, using two different circular staplers will be compared
Time Frame
1 hour following the end of the operation
Secondary Outcome Measure Information:
Title
Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers
Description
the number of hemostatic sutures required to get perfect hemostasis during stapled hemorrhoidopexy using 2 different staplers for III degree hemorrhoids
Time Frame
1 hour after each operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dept of Emergency and Organ transplantation
City
Bari
ZIP/Postal Code
70124
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Safety and Short Term Effectiveness of EEA Versus PPH Stapler for III Degree Hemorrhoids
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