Multicenter Prospective Trial on Hemorrhoids

Launched by STONY BROOK UNIVERSITY · Aug 7, 2017

Keywords

ClinConnect Summary

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 scheduled for either Ferguson or THD hemorrhoidectomy, the surgery is NOT part of the research. Although a randomized study would control for variation among surgeons, this study design provides the best patient safety since the surgeons will perform the technique they do most frequently. Variability in the patient population will be managed with a conservative sample size, which allows for a ...

Gender

ALL

Eligibility criteria

• 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