THD Versus Open Haemorrhoidectomy

Hemorrhoids Clinical Trial

Official title:

Transanal Haemorrhoidal Dearterialization (THD) Versus Open Haemorrhoidectomy for the Treatment of Haemorrhoids. An Open Prospective Randomized Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02061176
• Other study ID #: Holbaek Haemorrhoid Study
• Status: Active, not recruiting
• Phase: N/A
• First received: February 11, 2014
• Last updated: December 1, 2017
• Start date: October 2013
• Est. completion date: December 2021

Study information

• Verified date: December 2017
• Source: Holbaek Sygehus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Procedure:
• Transanal Haemorrhoidal Dearterialization

• Open Haemorrhoidectomy

Locations

Country	Name	City	State
Denmark	Departement of Surgery, Holbaek County Hospital.	Holbaek

Sponsors (1)

Lead Sponsor	Collaborator
Holbaek Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-year and 5-years postoperatively
Secondary	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.	14 days postoperatively
Secondary	Complications	Early and late complications are registered at 3 and 12 months and 5 years follow up.	1-year and 5-years postoperatively
Secondary	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.	1-year and 5-years postoperatively
Secondary	Quality of Life	QoL is evaluated using Short Health Scale, Short Form(SF)-36 and EQ-5D preoperatively, 1-year and 5-years postoperatively.	1-year and 5-years postoperatively
Secondary	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).	1-year and 5-years postoperatively