Multicenter Prospective Trial on Hemorrhoids (NCT03245086) | Clinical Trial Compass
UnknownNot Applicable
Multicenter Prospective Trial on Hemorrhoids
United States492 participantsStarted 2016-08-17
Plain-language 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 examination performed by a colorectal surgeon.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
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 Criteria:
* 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