Multicenter Prospective Trial on Hemorrhoids

NCT ID: NCT03245086

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 492 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-17
• Study Completion Date: 2019-08-31

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.

Conditions

Hemorrhoids

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Transanal hemorrhoid dearterialization (THD)

Patients with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns undergoing transanal hemorrhoid dearterialization (THD).

Transanal hemorrhoid dearterialization

Intervention Type: 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.

Ferguson hemorrhoidectomy

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

Ferguson hemorrhoidectomy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Other Intervention Names

THD

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

THD America

UNKNOWN

Sponsor Role: collaborator

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

George Angelos

George Angelos, MD, MS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George Angelos, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Suresh Yelika, MD

Role: CONTACT

suresh.yelika@stonybrookmedicine.edu

631-638-2215

Mahir Gachabayov, MD

Role: CONTACT

gachabayovmahir@gmail.com

Facility Contacts

Suresh Yelika, MD

Role: primary

suresh.yelika@stonybrookmedicine.edu

631-638-2215

Mahir Gachabayov, MD

Role: backup

gachabayovmahir@gmail.com

References

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

Reference Type: BACKGROUND

PMID: 13652788 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25213152 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33238029 (View on PubMed)

Other Identifiers

934287

Identifier Type: -

Identifier Source: org_study_id