Multicenter Prospective Trial on Hemorrhoids

NCT03245086 | Unknown DMC FDA Device

• 1 other identifier: 934287
• Study Type: observational
• Target: 492
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative complications

  30 days

Study Arms (2)

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

Ferguson hemorrhoidectomy

Patients with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns undergoing Ferguson hemorrhoidectomy.

Procedure: Ferguson hemorrhoidectomy

Interventions

Transanal hemorrhoid dearterialization DEVICE

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.

Also known as: THD

Transanal hemorrhoid dearterialization (THD)

Ferguson hemorrhoidectomy PROCEDURE

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.

Ferguson hemorrhoidectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Stony Brook University: lead
• THD America: collaborator

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

RECRUITING

Related Publications (3)

• FERGUSON JA, HEATON JR. Closed hemorrhoidectomy. Dis Colon Rectum. 1959 Mar-Apr;2(2):176-9. doi: 10.1007/BF02616713. No abstract available.

  PMID: 13652788 BACKGROUND

• 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.

  PMID: 25213152 BACKGROUND

• 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.

  PMID: 33238029 DERIVED

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• George Angelos, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suresh Yelika, MD

CONTACT

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

Mahir Gachabayov, MD

CONTACT

gachabayovmahir@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: George Angelos, MD, MS

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 10, 2017
• Study Start: August 17, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2019
• Last Updated: August 10, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)