THD Versus Open Haemorrhoidectomy

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

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 Overview

• Status: Unknown
• Conditions: Hemorrhoids
• Intervention / Treatment: Procedure: Transanal Haemorrhoidal Dearterialization; Procedure: Open Haemorrhoidectomy

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Holbaek, Denmark, 4300
    • Departement of Surgery, Holbaek County Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transanal Haemorrhoidal Dearterialization; Patients randomised to Transanal Haemorrhoidal Dearterialization.	Procedure: Transanal Haemorrhoidal Dearterialization; Other Names: Hemorrhoidal Artery Ligation
Active Comparator: Open Haemorrhoidectomy; Patients randomised to Open Haemorrhoidectomy	Procedure: Open Haemorrhoidectomy; Other Names: Milligan Morgan; Haemorrhoidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Complications	Early and late complications are registered at 3 and 12 months and 5 years follow up.	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.	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.	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).	1-year and 5-years postoperatively

Collaborators and Investigators

• Sponsor: Holbaek Sygehus
• Investigators: Principal Investigator: Gunnar Olaison, MD, Ph.D, Departement of Surgery, Holbaek County Hospital

Publications and helpful links

General Publications

• Rorvik HD, Campos AH, Styr K, Ilum L, McKinstry GK, Brandstrup B, Olaison G. Minimal Open Hemorrhoidectomy Versus Transanal Hemorrhoidal Dearterialization: The Effect on Symptoms: An Open-Label Randomized Controlled Trial. Dis Colon Rectum. 2020 May;63(5):655-667. doi: 10.1097/DCR.0000000000001588.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: February 11, 2014
• First Posted (Estimate): February 12, 2014

Study Record Updates

• Last Update Posted (Actual): December 4, 2017
• Last Update Submitted That Met QC Criteria: December 1, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Hemorrhoids; Haemorrhoids; Open Haemorrhoidectomy; Transanal Haemorrhoidal Dearterialization; Transanal Hemorrhoidal Dearterialisation; Open Hemorrhoidectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: Holbaek Haemorrhoid Study