Trial record 3 of 5 for:    Open Studies | "Hemorrhoidectomy"

THD Versus Open Haemorrhoidectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Holbaek Sygehus
Sponsor:
Information provided by (Responsible Party):
Per Olov Gunnar Olaison, Holbaek Sygehus
ClinicalTrials.gov Identifier:
NCT02061176
First received: February 11, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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 Intervention
Hemorrhoids
Procedure: Transanal Haemorrhoidal Dearterialization
Procedure: Open Haemorrhoidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transanal Haemorrhoidal Dearterialization (THD) Versus Open Haemorrhoidectomy for the Treatment of Haemorrhoids. An Open Prospective Randomized Study.

Resource links provided by NLM:


Further study details as provided by Holbaek Sygehus:

Primary Outcome Measures:
  • Haemorrhoidal Symptoms [ Time Frame: 1-year postoperatively ] [ Designated as safety issue: No ]

    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 postoperatively.



Secondary Outcome Measures:
  • Postoperative pain [ Time Frame: 14 days postoperatively ] [ Designated as safety issue: No ]
    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.

  • Complications [ Time Frame: 1-year postoperatively ] [ Designated as safety issue: Yes ]
    Early and late complications are registered at 3 and 12 months follow up.

  • Anal continence [ Time Frame: 1-year postoperatively ] [ Designated as safety issue: Yes ]
    Effect on anal continence is evaluated by Wexner Anal Incontinence Score and Revised Faecal Incotinence Score (RFIS) preoperatively, 3- and 12 months postoperatively.

  • Quality of Life [ Time Frame: 1-year postoperatively ] [ Designated as safety issue: No ]
    QoL is evaluated using Short Form(SF)-36 and EQ-5D preoperatively and 1-year postoperatively.

  • Health cost analysis [ Time Frame: 1-year postoperatively ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 90
Study Start Date: January 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061176

Locations
Denmark
Departement of Surgery, Holbaek County Hospital. Recruiting
Holbaek, Denmark, 4300
Contact: Gunnar Olaison, MD, Ph.D       poo@regionsjaelland.dk   
Contact: Havard Roervik, MD       hdro@regionsjaelland.dk   
Principal Investigator: Gunnar Olaison, MD, Ph.D         
Sponsors and Collaborators
Holbaek Sygehus
Investigators
Principal Investigator: Gunnar Olaison, MD, Ph.D Departement of Surgery, Holbaek County Hospital
  More Information

No publications provided

Responsible Party: Per Olov Gunnar Olaison, MD, PhD, Holbaek Sygehus
ClinicalTrials.gov Identifier: NCT02061176     History of Changes
Other Study ID Numbers: Holbaek Haemorrhoid Study
Study First Received: February 11, 2014
Last Updated: February 11, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by 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

ClinicalTrials.gov processed this record on July 20, 2014