Clinical trial NCT03245086: Multicenter Prospective Trial on Hemorrhoids
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemorrhoids
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: THD America
First posted: 2017-08-10
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: 1-year recurrence rates
timeFrame: 1-year
Secondary outcomes:
measure: Postoperative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: George Angelos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: FERGUSON JA, HEATON JR. Closed hemorrhoidectomy. Dis Colon Rectum. 1959 Mar-Apr;2(2):176-9. doi: 10.1007/BF02616713. No abstract available.
citation: 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.
citation: 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.