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THD Versus Open Haemorrhoidectomy

H

Holbaek Sygehus

Status

Unknown

Conditions

Hemorrhoids

Treatments

Procedure: Open Haemorrhoidectomy
Procedure: Transanal Haemorrhoidal Dearterialization

Study type

Interventional

Funder types

Other

Identifiers

NCT02061176
Holbaek Haemorrhoid Study

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Transanal Haemorrhoidal Dearterialization
Experimental group
Description:
Patients randomised to Transanal Haemorrhoidal Dearterialization.
Treatment:
Procedure: Transanal Haemorrhoidal Dearterialization
Open Haemorrhoidectomy
Active Comparator group
Description:
Patients randomised to Open Haemorrhoidectomy
Treatment:
Procedure: Open Haemorrhoidectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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