THD Versus Open Haemorrhoidectomy

Not Applicable

• Conditions: Hemorrhoids
• Interventions: Procedure: Transanal Haemorrhoidal Dearterialization; Procedure: Open Haemorrhoidectomy

• Registration Number: NCT02061176
• Lead Sponsor: Holbaek Sygehus

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 available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-12
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-01
• Last Update Posted: 2017-12-04
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transanal Haemorrhoidal Dearterialization	Transanal Haemorrhoidal Dearterialization	Patients randomised to Transanal Haemorrhoidal Dearterialization.
Open Haemorrhoidectomy	Open Haemorrhoidectomy	Patients randomised to Open Haemorrhoidectomy

Primary Outcome Measures

Name	Time	Method
Haemorrhoidal Symptoms	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	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	1-year and 5-years postoperatively	Early and late complications are registered at 3 and 12 months and 5 years follow up.
Anal continence	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	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	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).

Trial Locations

Locations (1)

Departement of Surgery, Holbaek County Hospital.; 🇩🇰 Holbaek, Denmark