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Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs. Suture Mucopexy Alone

Primary Purpose

Third Degree Hemorrhoids

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mucopexy +/- Doppler-guided haemorrhoidal artery ligation
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Third Degree Hemorrhoids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • grade III haemorrhoids
  • ≥18 years of age

Exclusion Criteria:

  • malignant gastrointestinal disease
  • inflammatory bowel disease
  • any type of proctological intervention (i.e., fistula surgery)
  • recurrent haemorrhoidal disease
  • anorectal trauma in the history

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    DG-HAL with mucopexy

    mucopexy alone

    Arm Description

    Mucopexy with DG-HAL is performed using a specific device consisting of a proctoscope equipped with a Doppler probe and a light source. The proctoscope model in our study has a sliding part comprising the operating window and Doppler probe for better proximal and distal movement without repositioning the proctoscope during mucopexy.

    Mucopexy without DG-HAL is performed using the same specific device consisting of a proctoscope equipped with a Doppler probe and a light source as described above.

    Outcomes

    Primary Outcome Measures

    pain assessment wit 1-month-pain diary

    Secondary Outcome Measures

    Full Information

    First Posted
    February 6, 2015
    Last Updated
    February 20, 2015
    Sponsor
    Medical University Innsbruck
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02372981
    Brief Title
    Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs. Suture Mucopexy Alone
    Official Title
    Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs. Suture Mucopexy Alone for the Treatment of Grade III Haemorrhoids: A Prospective-randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2010 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University Innsbruck

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Novel minimally invasive techniques were established for prolapsing haemorrhoids to minimise the drawbacks of the golden standard of haemorrhoidal treatment, conventional haemorrhoidectomy techniques. Ligation techniques, such as Doppler-guided haemorrhoidal artery ligation (DG-HAL), were introduced to reduce the arterial inflow of the AVP and thus prevent the haemorrhoidal zone from being part of the continence system. Apart from inappropriate application of this surgical alternative for higher grade haemorrhoids, high recurrence rates of up to 38% after DG-HAL are due to technical failure of the ligation technique itself. This is a prospective randomised controlled trial to evaluate the efficacy of additional Doppler-guided ligation of submucosal haemorrhoidal arteries in patients with symptomatic grade III haemorrhoids.
    Detailed Description
    All consecutive patients with symptomatic grade III haemorrhoids are randomly allocated to one of the two study arms: (A) DG-HAL with mucopexy or (B) mucopexy alone. Endpoints are pain, faecal incontinence, bleeding, residual prolapse and vascularisation of the anorectal vascular plexus. Vascularisation of the anorectal vascular plexus is assessed by transperineal contrast enhanced ultrasound.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Third Degree Hemorrhoids

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DG-HAL with mucopexy
    Arm Type
    Experimental
    Arm Description
    Mucopexy with DG-HAL is performed using a specific device consisting of a proctoscope equipped with a Doppler probe and a light source. The proctoscope model in our study has a sliding part comprising the operating window and Doppler probe for better proximal and distal movement without repositioning the proctoscope during mucopexy.
    Arm Title
    mucopexy alone
    Arm Type
    Active Comparator
    Arm Description
    Mucopexy without DG-HAL is performed using the same specific device consisting of a proctoscope equipped with a Doppler probe and a light source as described above.
    Intervention Type
    Device
    Intervention Name(s)
    mucopexy +/- Doppler-guided haemorrhoidal artery ligation
    Intervention Description
    Mucopexy with or without DG-HAL is performed using a specific device consisting of a proctoscope equipped with a Doppler probe and a light source. The proctoscope model in our study has a sliding part comprising the operating window and Doppler probe for better proximal and distal movement without repositioning the proctoscope during mucopexy.
    Primary Outcome Measure Information:
    Title
    pain assessment wit 1-month-pain diary
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: grade III haemorrhoids ≥18 years of age Exclusion Criteria: malignant gastrointestinal disease inflammatory bowel disease any type of proctological intervention (i.e., fistula surgery) recurrent haemorrhoidal disease anorectal trauma in the history

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26787597
    Citation
    Aigner F, Kronberger I, Oberwalder M, Loizides A, Ulmer H, Gruber L, Pratschke J, Peer S, Gruber H. Doppler-guided haemorrhoidal artery ligation with suture mucopexy compared with suture mucopexy alone for the treatment of Grade III haemorrhoids: a prospective randomized controlled trial. Colorectal Dis. 2016 Jul;18(7):710-6. doi: 10.1111/codi.13280.
    Results Reference
    derived

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    Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs. Suture Mucopexy Alone

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