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THD Versus Open Haemorrhoidectomy

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ClinicalTrials.gov Identifier: NCT02061176
Recruitment Status : Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Per Olov Gunnar Olaison, Holbaek Sygehus

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hemorrhoids Procedure: Transanal Haemorrhoidal Dearterialization Procedure: Open Haemorrhoidectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transanal Haemorrhoidal Dearterialization (THD) Versus Open Haemorrhoidectomy for the Treatment of Haemorrhoids. An Open Prospective Randomized Study.
Actual Study Start Date : October 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
Experimental: Transanal Haemorrhoidal Dearterialization
Patients randomised to Transanal Haemorrhoidal Dearterialization.
Procedure: Transanal Haemorrhoidal Dearterialization
Other Name: Hemorrhoidal Artery Ligation

Active Comparator: Open Haemorrhoidectomy
Patients randomised to Open Haemorrhoidectomy
Procedure: Open Haemorrhoidectomy
Other Names:
  • Milligan Morgan
  • Haemorrhoidectomy




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02061176


Locations
Denmark
Departement of Surgery, Holbaek County Hospital.
Holbaek, Denmark, 4300
Sponsors and Collaborators
Holbaek Sygehus
Investigators
Principal Investigator: Gunnar Olaison, MD, Ph.D Departement of Surgery, Holbaek County Hospital

Responsible Party: Per Olov Gunnar Olaison, MD, PhD, Holbaek Sygehus
ClinicalTrials.gov Identifier: NCT02061176     History of Changes
Other Study ID Numbers: Holbaek Haemorrhoid Study
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: December 2017

Keywords provided by Per Olov Gunnar Olaison, Holbaek Sygehus:
Hemorrhoids
Haemorrhoids
Transanal Haemorrhoidal Dearterialization
Transanal Hemorrhoidal Dearterialisation
Open Haemorrhoidectomy
Open Hemorrhoidectomy

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases