Multicenter Prospective Trial on Hemorrhoids
|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.|
|ClinicalTrials.gov Identifier: NCT03245086|
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment|
|Hemorrhoids||Device: Transanal hemorrhoid dearterialization Procedure: Ferguson hemorrhoidectomy|
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 [Patient Registry]|
|Estimated Enrollment :||492 participants|
|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|
|Actual Study Start Date :||August 17, 2016|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2019|
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
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.
- 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.
- 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)
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
|Contact: Suresh Yelika, MDfirstname.lastname@example.org|
|Contact: Mahir Gachabayov, MDemail@example.com|
|United States, New York|
|Stony Brook University||Recruiting|
|Stony Brook, New York, United States, 11794|
|Contact: Suresh Yelika, MD 631-638-2215 firstname.lastname@example.org|
|Contact: Mahir Gachabayov, MD email@example.com|
|Principal Investigator:||George Angelos, MD||Stony Brook University|