Multicenter Prospective Trial on Hemorrhoids

• Conditions: Hemorrhoids
• Interventions: Device: Transanal hemorrhoid dearterialization; Procedure: Ferguson hemorrhoidectomy

• Registration Number: NCT03245086
• Lead Sponsor: Stony Brook University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-08-17
• Status Verified: 2017-08
• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-07
• Last Update Submitted: 2017-08-07
• Study First Posted: 2017-08-10
• Last Update Posted: 2017-08-10
• Primary Completion: 2018-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 492

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transanal hemorrhoid dearterialization (THD)	Transanal hemorrhoid dearterialization	Patients with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns undergoing transanal hemorrhoid dearterialization (THD).
Ferguson hemorrhoidectomy	Ferguson hemorrhoidectomy	Patients with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns undergoing Ferguson hemorrhoidectomy.

Primary Outcome Measures

Name	Time	Method
1-year recurrence rates	1-year	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	30 days	The secondary outcomes include postoperative complications (i.e. urinary retention, constipation, dysuria, pruritis ani, anal pain, anal stenosis, unhealed wound, fissure, fecal urgency, incontinence- flatus, incontinence- stool)

Trial Locations

Locations (1)

Stony Brook University; 🇺🇸 Stony Brook, New York, United States