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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

Tracking Information
First Submitted Date  ICMJE February 11, 2014
First Posted Date  ICMJE February 12, 2014
Last Update Posted Date December 4, 2017
Actual Study Start Date  ICMJE October 2013
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
Haemorrhoidal Symptoms [ Time Frame: 1-year 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 postoperatively.
Change History Complete list of historical versions of study NCT02061176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
  • 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.
  • Complications [ Time Frame: 1-year postoperatively ]
    Early and late complications are registered at 3 and 12 months follow up.
  • Anal continence [ Time Frame: 1-year postoperatively ]
    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 ]
    QoL is evaluated using Short Form(SF)-36 and EQ-5D preoperatively and 1-year postoperatively.
  • Health cost analysis [ Time Frame: 1-year 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE THD Versus Open Haemorrhoidectomy
Official Title  ICMJE Transanal Haemorrhoidal Dearterialization (THD) Versus Open Haemorrhoidectomy for the Treatment of Haemorrhoids. An Open Prospective Randomized Study.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemorrhoids
Intervention  ICMJE
  • Procedure: Transanal Haemorrhoidal Dearterialization
    Other Name: Hemorrhoidal Artery Ligation
  • Procedure: Open Haemorrhoidectomy
    Other Names:
    • Milligan Morgan
    • Haemorrhoidectomy
Study Arms  ICMJE
  • Experimental: Transanal Haemorrhoidal Dearterialization
    Patients randomised to Transanal Haemorrhoidal Dearterialization.
    Intervention: Procedure: Transanal Haemorrhoidal Dearterialization
  • Active Comparator: Open Haemorrhoidectomy
    Patients randomised to Open Haemorrhoidectomy
    Intervention: Procedure: Open Haemorrhoidectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2014)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02061176
Other Study ID Numbers  ICMJE Holbaek Haemorrhoid Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Per Olov Gunnar Olaison, Holbaek Sygehus
Study Sponsor  ICMJE Holbaek Sygehus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gunnar Olaison, MD, Ph.D Departement of Surgery, Holbaek County Hospital
PRS Account Holbaek Sygehus
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP