Multicenter Prospective Trial on Hemorrhoids

Stony Brook University

Status

Unknown

Conditions

Hemorrhoids

Treatments

Procedure: Ferguson hemorrhoidectomy

Device: Transanal hemorrhoid dearterialization

Study type

Observational

Funder types

Other

Identifiers

NCT03245086

934287

Details and patient eligibility

About

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.

Full 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 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 multivariate analysis of the sample populations if any confounding variables are noted during initial data analyses. In addition, the variability will be minimized with stringent and detailed inclusion/exclusion criteria in terms of hemorrhoidal disease. Patients will be enrolled and followed for one year. Participating surgeons will be credentialed and each participating surgeon will enroll up to ten consecutive patients.

The primary endpoint of this study is to compare Ferguson hemorrhoidectomy and THD in terms of recurrence rates at one-year. Recurrence is defined as prolapsing internal hemorrhoids at physical examination performed by a colorectal surgeon.

Enrollment

492 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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