NCT01244672

Brief Summary

The purpose of this study is to compare the frequency and severity of postoperative( after surgery) pain between two surgical techniques for treating severe hemorrhoids. The two techniques are called: transanal hemorrhoidal dearterialization (THD) and standard surgical excision (removal) of the hemorrhoids

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 5, 2012

Status Verified

October 1, 2012

Enrollment Period

2.8 years

First QC Date

November 18, 2010

Last Update Submit

October 3, 2012

Conditions

Hemorrhoids

Keywords

HemorrhoidsTHDFerguson

Outcome Measures

Primary Outcomes (1)

  • Post operative pain

    Patient reports pain levels at 14 days post surgery

    14 days

Secondary Outcomes (1)

  • complications

    30 days

Study Arms (2)

Trans-anal dearterialization

ACTIVE COMPARATOR

24 patients were assigned to the Transanal hemorrhoidal dearterialization with mucopexy arm, which is a Doppler guided procedure for suture ligation of hemorrhidal arteries rather than excisional

Procedure: THD

Ferguson

ACTIVE COMPARATOR

17 patients were randomized to Ferguson method, which is the operative gold standard for hemorrhoids. This is an excisional surgery.

Procedure: Ferguson

Interventions

FergusonPROCEDURE

This is a modification of the Milligan-Morgan technique, whereby the incisions are totally or partially closed with absorbable running suture. A retractor is used to expose the hemorrhoidal tissue, which is then removed surgically. The remaining tissue is either sutured or is sealed through the coagulation effects of a surgical device.

Ferguson
THDPROCEDURE

Transanal hemorrhoidal dearterialization will be performed using an endoscopic ultrasonic probe. Approximately 7-8 hemorrhoidal arteries will be ligated at 1, 3, 5, 7, 9, 11 o'clock position as previously described in the literature. The ligation will be performed using a vicryl suture. The ultrasonic probe locates the arterial signal.

Trans-anal dearterialization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients visiting colorectal outpatient office at Stony Book Medical Center, with the diagnosis of 3rd or 4th degree hemorrhoids requiring hemorrhoidectomy will be invited to participate in this study. The diagnosis of hemorrhoids will be established by a colorectal surgeon based on following criteria:
  • physical exam
  • anoscopy or proctoscopy

You may not qualify if:

  • first and second degree hemorrhoids
  • recurrent hemorrhoids after previous surgical treatment
  • history of HIV
  • history of inflammatory bowel disease
  • inability to give informed consent due to mental disability
  • age younger than 18
  • history of colon, rectal or anal cancer
  • thrombosed hemorrhoids
  • pregnant women
  • non English speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University Hospital Medical Center

Stony Brook, New York, 11794-8191, United States

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Roberto Bergamaschi, MD, PhD

    Stony Brook University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chief, Division of colon and rectal surgery

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 19, 2010

Study Start

December 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 5, 2012

Record last verified: 2012-10

Locations

US(1)