THD Versus Open Haemorrhoidectomy

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)

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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