Safety and Short Term Effectiveness of EEA Versus PPH Stapler for III Degree Hemorrhoids
EEA/PPH2011
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 8, 2011
CompletedFirst Posted
Study publicly available on registry
August 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 11, 2013
December 1, 2013
2.8 years
August 8, 2011
December 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 hour following the end of the operation
Secondary Outcomes (1)
Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers
1 hour after each operation
Study Arms (2)
EEA group
EXPERIMENTALGroup of patients with III degree hemorrhoids treated by EEA stapler
PPH group
ACTIVE COMPARATORgroup of patients with III degree hemorrhoids treated by PPH stapler
Interventions
stapled hemorrhoidopexy will be performed using the EEA stapler Covidien
Eligibility Criteria
You may qualify if:
- III degree Hemorrhoids
- written informed consent
- mental ability to understand the procedure
You may not qualify if:
- Previous treatments for hemorrhoids or other proctological diseases
- Fecal Incontinence
- Chronic inflammatory bowel disease
- Anal sphincter lesions
- coagulative defects
- obstructed defecation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept of Emergency and Organ transplantation
Bari, 70124, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
August 8, 2011
First Posted
August 10, 2011
Study Start
March 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 11, 2013
Record last verified: 2013-12