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Multicenter Prospective Trial on Hemorrhoids

This study is currently recruiting participants.
Verified August 2017 by George Angelos, Stony Brook University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03245086
First Posted: August 10, 2017
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
THD America
Information provided by (Responsible Party):
George Angelos, Stony Brook University
  Purpose
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.

Condition Intervention
Hemorrhoids Device: Transanal hemorrhoid dearterialization Procedure: Ferguson hemorrhoidectomy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: 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

Resource links provided by NLM:


Further study details as provided by George Angelos, Stony Brook University:

Primary Outcome Measures:
  • 1-year recurrence rates [ Time Frame: 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:
  • Postoperative complications [ Time Frame: 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)


Estimated Enrollment: 492
Actual Study Start Date: August 17, 2016
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245086


Contacts
Contact: Suresh Yelika, MD 631-638-2215 suresh.yelika@stonybrookmedicine.edu
Contact: Mahir Gachabayov, MD gachabayovmahir@gmail.com

Locations
United States, New York
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
Contact: Suresh Yelika, MD    631-638-2215    suresh.yelika@stonybrookmedicine.edu   
Contact: Mahir Gachabayov, MD       gachabayovmahir@gmail.com   
Sponsors and Collaborators
Stony Brook University
THD America
Investigators
Principal Investigator: George Angelos, MD Stony Brook University
  More Information

Publications:
Responsible Party: George Angelos, George Angelos, MD, MS, Stony Brook University
ClinicalTrials.gov Identifier: NCT03245086     History of Changes
Other Study ID Numbers: 934287
First Submitted: August 7, 2017
First Posted: August 10, 2017
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be available to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases