Multicenter Prospective Trial on Hemorrhoids

Status unconfirmed

Conditions studied: Hemorrhoids

In brief

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.

Key facts

Study ID

NCT03245086

Run by

Stony Brook University

People needed

492

Starts

2016-08-17

Expected to finish

2019-08-01

Last updated by the study team

2017-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Stony Brook University — Stony Brook, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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