THD Versus Open Haemorrhoidectomy

NCT ID: NCT02061176

Last Updated: 2017-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Hemorrhoids

Keywords

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Hemorrhoids Haemorrhoids Transanal Haemorrhoidal Dearterialization Transanal Hemorrhoidal Dearterialisation Open Haemorrhoidectomy Open Hemorrhoidectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transanal Haemorrhoidal Dearterialization

Patients randomised to Transanal Haemorrhoidal Dearterialization.

Group Type EXPERIMENTAL

Transanal Haemorrhoidal Dearterialization

Intervention Type PROCEDURE

Open Haemorrhoidectomy

Patients randomised to Open Haemorrhoidectomy

Group Type ACTIVE_COMPARATOR

Open Haemorrhoidectomy

Intervention Type PROCEDURE

Interventions

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Transanal Haemorrhoidal Dearterialization

Intervention Type PROCEDURE

Open Haemorrhoidectomy

Intervention Type PROCEDURE

Other Intervention Names

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Hemorrhoidal Artery Ligation Milligan Morgan Haemorrhoidectomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Holbaek Sygehus

OTHER

Sponsor Role lead

Responsible Party

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Per Olov Gunnar Olaison

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gunnar Olaison, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Departement of Surgery, Holbaek County Hospital

Locations

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Departement of Surgery, Holbaek County Hospital.

Holbæk, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 31996581 (View on PubMed)

Other Identifiers

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Holbaek Haemorrhoid Study

Identifier Type: -

Identifier Source: org_study_id