ClinicalTrials.gov
ClinicalTrials.gov Menu

Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01647763
Recruitment Status : Recruiting
First Posted : July 24, 2012
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Lukas Marti, Cantonal Hospital of St. Gallen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Background:

Hemorrhoids of grade 3 and 4 can be treated either by conventional, rather invasive procedures, like Milligan-Morgan or Ferguson or by modern, less invasive procedures with less postoperative pain. Doppler guided hemorrhoidal artery ligation and stapled hemorrhoidopexy are examples for such modern procedures. Hemorrhoidal artery ligation causes less post operative pain than stapled hemorrhoidopexy, however the former has a higher recurrence rate. Combining hemorrhoidal artery ligation with rectoanal repair should reduce the recurrence rate without increasing the post operative pain.

Hypothesis and aim:

The study tries to prove the assumption that combined hemorrhoidal artery ligation and rectoanal repair cause less pain and have less post operative complications than stapled hemorrhoidopexy.


Condition or disease Intervention/treatment Phase
Hemorrhoids Procedure: Hemorrhoidal artery ligation with rectoanal repair Procedure: Stapled hemorrhoidopexy Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy
Study Start Date : July 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: HAL/RAR
hemorrhoidal artery ligation with rectoanal repair
 Procedure: Hemorrhoidal artery ligation with rectoanal repair

Hemorrhoidal arteries will be detected using an ultrasound Doppler probe. The arteries will be sutured with at least 4 Z-sutures.

In the area with the 3 largest knots a purse string suture will be placed.

Other Names:
  • HAL (hemorrhoidal artery ligation)
  • RAR (rectoanal repair)
Active Comparator: Stapled hemorrhoidopexy

procedure for prolapse and hemorrhoids (PPH)

Resection using a circular stapler

 Procedure: Stapled hemorrhoidopexy
A purse string suture will be placed just below the hemorrhoidal cushion. Fixing the suture around the shaft of a circular PPH 03 stapler (Ethicon Endo-Surgery). Hemorrhoids will be removed by firing the stapler. Sufficiency of the stapler line will be examined through a proctoscope. Eventual sources of bleeding will be sutured.
Other Name: Longo procedure


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Pain [ Time Frame: between 6:00 am and 8:00 am the day after surgery ]

    Visual analogue scale (VAS).

    Additionally recording of the pain medication used.



Secondary Outcome Measures :
  1. Pain [ Time Frame: 8 h after surgery ]

    Measuring post operative pain using the visual analogue scale (0 - 10).

    Additionally recording of the pain medication used.


  2. Pain [ Time Frame: 30 days after surgery ]
    visual analogue scale

  3. Pain [ Time Frame: 1 year after surgery ]
    visual analogue scale

  4. Pain [ Time Frame: 2 years after surgery ]
    visual analogue scale

  5. post operative surgical complications [ Time Frame: within 30 post operative days ]
    Number and severity according to the Dindo classification (Ann Surg 240:205)

  6. duration of medical leave [ Time Frame: up to 3 months after surgery ]
    data will be obtained from primary care physician

  7. Continence [ Time Frame: 30 days after surgery ]

    Physician obtains data to calculate the Wexner Score (Dis Colon Rectum 36:77).

    Score will be compared with pre-operative score.


  8. Continence [ Time Frame: 1 year after surgery ]
    Wexner score

  9. Continence [ Time Frame: 2 years after surgery ]

    Wexner score

    Additionally anorectal manometry (results will be compared with pre-operative data).



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hemorrhoids grade 3
  • no active anti-coagulation treatment
  • no hemorrhoidal recurrence
  • no previous surgery on rectum or anus
  • no previous local radiotherapy
  • no mental incapacities, good study compliance can be expected
  • no severe incontinence (Wexner score > 12)
  • no severe comorbidities
  • no inflammatory anal diseases (abscesses, fistulas)
  • informed consent

Exclusion Criteria:

  • patient wish
  • inoperability with the assigned intervention, switching to other treatment method
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647763


Contacts
Contact: Lukas Marti, MD +41 71 494 1339 lukas.marti@kssg.ch
Contact: Stephan Bischofberger, MD +41 71 494 1111

Locations
Switzerland
Kantonsspital Rorschach Recruiting
_Rorschach, Switzerland, 9400
Contact: Susanne Bock, MD    +41 71 858 1111    susanne.bock@kssg.ch   
Contact: Lukas Marti, MD       lukas.marti@kssg.ch   
Kantonsspital St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Contact: Lukas Marti, MD    +41 71 494 1339    lukas.marti@kssg.ch   
Principal Investigator: Lukas Marti, MD         
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
Principal Investigator: Lukas Marti, MD Cantonal Hospital St. Gallen, Department of Surgery
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Website of the Department of Surgery (in German only)  This link exits the ClinicalTrials.gov site

Responsible Party: Lukas Marti, Leitender Arzt (attending surgeon), Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01647763     History of Changes
Other Study ID Numbers: EKSG11/042
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lukas Marti, Cantonal Hospital of St. Gallen:
Hemorrhoids

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases