Status:
UNKNOWN
Multicenter Prospective Trial on Hemorrhoids
Lead Sponsor:
Stony Brook University
Collaborating Sponsors:
THD America
Conditions:
Hemorrhoids
Eligibility:
All Genders
18+ years
Brief Summary
This study will compare Ferguson hemorrhoidectomy and THD in terms of one-year recurrence in a large population (N=492). Recurrence is defined as prolapsing internal hemorrhoids at physical examinatio...
Detailed Description
This is a multicenter, parallel arm, non-randomized prospective data collection trial comparing Ferguson hemorrhoidectomy and THD in terms of recurrence rates at one-year. All subjects will already be...
Eligibility Criteria
Inclusion
- Patient must be:
- At least 18 years-old
- Able to sign informed consent
- Presenting with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns at physical examination and scheduled for either Ferguson or THD hemorrhoidectomy.
Exclusion
- Any prior anorectal surgery except for conventional office-based interventions (rubber band ligation, sclerotherapy, and infrared coagulation)
- Prior pelvic radiotherapy
- Inflammatory bowel diseases
- Pre-existing fecal incontinence (Wexner score5 ≥8)
- Pre-existing chronic anal diseases
- Grades III and IV gynecological and obstetrical trauma per medical history and/or physical examination
- Connective tissue disorders
- Subject is pregnant
- Subject is under incarceration
Key Trial Info
Start Date :
August 17 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2019
Estimated Enrollment :
492 Patients enrolled
Trial Details
Trial ID
NCT03245086
Start Date
August 17 2016
End Date
August 1 2019
Last Update
August 10 2017
Active Locations (1)
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1
Stony Brook University
Stony Brook, New York, United States, 11794