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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

1-year recurrence rates

Timeframe: 1-year

Trial details

NCT IDNCT03245086

SponsorStony Brook University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-08

Contact for this trial

Suresh Yelika, MD

631-638-2215 suresh.yelika@stonybrookmedicine.edu

View on ClinicalTrials.gov More Hemorrhoids trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.