Multicenter Prospective Trial on Hemorrhoids

Multi-center, Non-randomized Prospective Observation Study Comparing Ferguson Hemorrhoidectomy and Transanal Hemorrhoidal Dearterialization (THD) for Prolapsed, Nonincarcerated, Reducible Hemorrhoids in Terms of 1-year Recurrence

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.

Study Overview

• Status: Unknown
• Conditions: Hemorrhoids
• Intervention / Treatment: Device: Transanal hemorrhoid dearterialization; Procedure: Ferguson hemorrhoidectomy

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 Type: Observational
• Enrollment (Anticipated): 492

Contacts and Locations

• Study Contact: Name: Suresh Yelika, MD; Phone Number: 631-638-2215; Email: suresh.yelika@stonybrookmedicine.edu
• Study Contact Backup: Name: Mahir Gachabayov, MD; Email: gachabayovmahir@gmail.com

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University
      • Contact: Suresh Yelika, MD; Phone Number: 631-638-2215; Email: suresh.yelika@stonybrookmedicine.edu
      • Contact: Mahir Gachabayov, MD; Email: gachabayovmahir@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns at physical examination and scheduled for either Ferguson or THD hemorrhoidectomy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transanal hemorrhoid dearterialization (THD); Patients with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns undergoing transanal hemorrhoid dearterialization (THD).	Device: Transanal hemorrhoid dearterialization; The hemorrhoids are operated in their natural position and not distorted by eversion The proctoscope is fully introduced transanally to reach the lower rectum. Under Doppler guidance, six arterial signals are found circumferentially above the dentate line. The approach to make the 'dearterialization' involves the transfixation of the rectal mucosa and submucosa to entrap the artery using a suture. Mucopexy is performed after the artery ligation with the same suture used for the dearterialization. Finally, the suture is tied to fix the mucopexy.; Other Names: THD
Ferguson hemorrhoidectomy; Patients with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns undergoing Ferguson hemorrhoidectomy.	Procedure: Ferguson hemorrhoidectomy; The hemorrhoids are operated in their natural position and not distorted by eversion. A Ferguson-Hill retractor is used to expose the hemorrhoids. Dissection with scissors is directed up to the dentate line where the fibers of the sphincter muscles are exposed and only a mucosal pedicle remains attached. A Buie-Smith crushing clamp is applied to this pedicle and the hemorrhoidal mass is excised at the superior level of the clamp. The pedicle is then ligated and the crushing clamp is removed. After dissection of the intermuscular septum is complete, the margins of the wound are drawn upward into the anal canal with stitches and are secured to the pedicle by the same suture. The remainder of the wound is closed with a stitch tied at the outer extremity of the wound using the same suture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year recurrence rates	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.	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	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)	30 days

Collaborators and Investigators

• Sponsor: Stony Brook University
• Collaborators: THD America
• Investigators: Principal Investigator: George Angelos, MD, Stony Brook University

Publications and helpful links

General Publications

• FERGUSON JA, HEATON JR. Closed hemorrhoidectomy. Dis Colon Rectum. 1959 Mar-Apr;2(2):176-9. doi: 10.1007/BF02616713. No abstract available.
• Ratto C, Parello A, Veronese E, Cudazzo E, D'Agostino E, Pagano C, Cavazzoni E, Brugnano L, Litta F. Doppler-guided transanal haemorrhoidal dearterialization for haemorrhoids: results from a multicentre trial. Colorectal Dis. 2015 Jan;17(1):O10-9. doi: 10.1111/codi.12779.
• Gachabayov M, Angelos G, George G, Kajmolli A, McGuirk M, Bergamaschi R. A Multicenter Prospective Non-Randomized Study Comparing Ferguson Hemorrhoidectomy and Transanal Hemorrhoidal Dearterialization for Prolapsed, Nonincarcerated, Reducible Hemorrhoids: A Study Protocol. Surg Technol Int. 2020 Nov 28;37:109-112.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: 934287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No