Recruiting

Observational Study

Sponsor:

Stony Brook University

Code:

NCT03245086

Conditions

Hemorrhoids

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transanal hemorrhoid dearterialization

Ferguson hemorrhoidectomy

Study Details

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

Study ID

NCT03245086

Start date

Aug 17, 2016

Status verified date

Aug, 2017

Completion date

Aug, 2019

Anticipated

Primary completion date

Aug, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

492 participants

Anticipated

Interventions and Outcome Measures

Arms

Transanal hemorrhoid dearterialization (THD)

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

Ferguson hemorrhoidectomy

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

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.

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.

Primary outcome measure

  • 1-year recurrence rates [ Time Frame: 1-year ]

Central Contacts and Locations

Central contacts

Locations

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11794

Contacts

More Information

Sponsor

Stony Brook University

Last update posted

Aug 10, 2017

Last verified

Aug, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2017-08-10.