THD Versus Open Haemorrhoidectomy

N/AUnknownNCT02061176

Holbaek Sygehus90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemorrhoids

Interventions

Transanal Haemorrhoidal DearterializationPROCEDURE

Open HaemorrhoidectomyPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Departement of Surgery, Holbaek County Hospital.

Holbæk, Denmark

Outcomes

Primary Outcomes

Haemorrhoidal Symptoms

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.

Time frame: 1-year and 5-years postoperatively

Secondary Outcomes

Postoperative pain

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.

Time frame: 14 days postoperatively

Complications

Early and late complications are registered at 3 and 12 months and 5 years follow up.

Time frame: 1-year and 5-years postoperatively

Anal continence

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.

Time frame: 1-year and 5-years postoperatively

Quality of Life

QoL is evaluated using Short Health Scale, Short Form(SF)-36 and EQ-5D preoperatively, 1-year and 5-years postoperatively.

Time frame: 1-year and 5-years postoperatively

Health cost analysis

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).

Time frame: 1-year and 5-years postoperatively

Data from ClinicalTrials.gov

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