NCT02061176

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 4, 2017

Status Verified

December 1, 2017

Enrollment Period

8.2 years

First QC Date

February 11, 2014

Last Update Submit

December 1, 2017

Conditions

Hemorrhoids

Keywords

HemorrhoidsHaemorrhoidsTransanal Haemorrhoidal DearterializationTransanal Hemorrhoidal DearterialisationOpen HaemorrhoidectomyOpen Hemorrhoidectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Postoperative pain

    14 days postoperatively

  • Complications

    1-year and 5-years postoperatively

  • Anal continence

    1-year and 5-years postoperatively

  • Quality of Life

    1-year and 5-years postoperatively

  • Health cost analysis

    1-year and 5-years postoperatively

Study Arms (2)

Transanal Haemorrhoidal Dearterialization

EXPERIMENTAL

Patients randomised to Transanal Haemorrhoidal Dearterialization.

Procedure: Transanal Haemorrhoidal Dearterialization

Open Haemorrhoidectomy

ACTIVE COMPARATOR

Patients randomised to Open Haemorrhoidectomy

Procedure: Open Haemorrhoidectomy

Interventions

Transanal Haemorrhoidal DearterializationPROCEDURE
Also known as: Hemorrhoidal Artery Ligation
Transanal Haemorrhoidal Dearterialization
Open HaemorrhoidectomyPROCEDURE
Also known as: Milligan Morgan, Haemorrhoidectomy
Open Haemorrhoidectomy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Surgery, Holbaek County Hospital.

Holbæk, 4300, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 31996581DERIVED

MeSH Terms

Conditions

Hemorrhoids

Interventions

Hemorrhoidectomy

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Gunnar Olaison, MD, Ph.D

    Departement of Surgery, Holbaek County Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 12, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

December 4, 2017

Record last verified: 2017-12

Locations

DK(1)