THD Versus Open Haemorrhoidectomy

December 1, 2017 updated by: Per Olov Gunnar Olaison, Holbaek Sygehus

Transanal Haemorrhoidal Dearterialization (THD) Versus Open Haemorrhoidectomy for the Treatment of Haemorrhoids. An Open Prospective Randomized Study.

A randomised study comparing Transanal Haemorrhoidal Dearterialization (THD) and Open Haemorrhoidectomy (OH) for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate the long-term effect on haemorrhoidal symptoms one year postoperatively.

Secondary endpoints are postoperative pain, complications, effect on anal continence, recovery and return to normal activity, quality of life and health cost analysis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Holbaek, Denmark, 4300
        • Departement of Surgery, Holbaek County Hospital.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient has Grade III-IV haemorrhoids or Grade II haemorrhoids with bleeding resistant to rubber band ligation or sclerotherapy
  • The patient has a Haemorrhoidal Symptom Score of 4 or more
  • The patient has an American Society of Anaesthesiologists (ASA) score I-II
  • The patient's age is 18-85 years at inclusion
  • The patient has had a colonoscopy, sigmoidoscopy or rigid rectoscopy within 3 months before inclusion

Exclusion Criteria:

  • The patient has had previous operation for haemorrhoids within the last 2 years
  • The patient has had previous operation for anal incontinence
  • The patient has an active anal fistula
  • The patient has an active anal fissure
  • The patient has anal incontinence for solid stools

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transanal Haemorrhoidal Dearterialization
Patients randomised to Transanal Haemorrhoidal Dearterialization.
Procedure: Transanal Haemorrhoidal Dearterialization
Other Names:
  • Hemorrhoidal Artery Ligation
Active Comparator: Open Haemorrhoidectomy
Patients randomised to Open Haemorrhoidectomy
Procedure: Open Haemorrhoidectomy
Other Names:
  • Milligan Morgan
  • Haemorrhoidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemorrhoidal Symptoms
Time Frame: 1-year and 5-years postoperatively

Five questions regarding haemorrhoidal symptoms (pain, bleeding, itching, soiling and prolapse) are used to grade the symptom load. Each symptom is graded from 0-4, giving a total score from 0-20.

The symptom score is registered preoperatively, 3 and 12 months and 5 years postoperatively.
1-year and 5-years postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 14 days postoperatively
Postoperative pain is registered using visual analog scale (VAS), by the hospital staff in the immediate postoperative course during hospital stay and by the patient the first 14 days postoperatively.
14 days postoperatively
Complications
Time Frame: 1-year and 5-years postoperatively
Early and late complications are registered at 3 and 12 months and 5 years follow up.
1-year and 5-years postoperatively
Anal continence
Time Frame: 1-year and 5-years postoperatively
Effect on anal continence is evaluated by Wexner Anal Incontinence Score and Revised Faecal Incotinence Score (RFIS) preoperatively, 3- and 12 months and 5 years postoperatively.
1-year and 5-years postoperatively
Quality of Life
Time Frame: 1-year and 5-years postoperatively
QoL is evaluated using Short Health Scale, Short Form(SF)-36 and EQ-5D preoperatively, 1-year and 5-years postoperatively.
1-year and 5-years postoperatively
Health cost analysis
Time Frame: 1-year and 5-years postoperatively
Health cost analysis will be based on an estimate of the cost of the operations, recovery of the patients and effect (need for further procedures or medical care).
1-year and 5-years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holbaek Sygehus

Investigators

  • Principal Investigator: Gunnar Olaison, MD, Ph.D, Departement of Surgery, Holbaek County Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 12, 2014

Study Record Updates

Last Update Posted (Actual)

December 4, 2017

Last Update Submitted That Met QC Criteria

December 1, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Holbaek Haemorrhoid Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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