Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Cantonal Hospital of St. Gallen
Sponsor:
Information provided by (Responsible Party):
Lukas Marti, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01647763
First received: July 18, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 Intervention
Hemorrhoids
Procedure: Hemorrhoidal artery ligation with rectoanal repair
Procedure: Stapled hemorrhoidopexy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • Pain [ Time Frame: between 6:00 am and 8:00 am the day after surgery ] [ Designated as safety issue: Yes ]

    Visual analogue scale (VAS).

    Additionally recording of the pain medication used.



Secondary Outcome Measures:
  • Pain [ Time Frame: 8 h after surgery ] [ Designated as safety issue: Yes ]

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

    Additionally recording of the pain medication used.


  • Pain [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
    visual analogue scale

  • Pain [ Time Frame: 1 year after surgery ] [ Designated as safety issue: Yes ]
    visual analogue scale

  • Pain [ Time Frame: 2 years after surgery ] [ Designated as safety issue: Yes ]
    visual analogue scale

  • post operative surgical complications [ Time Frame: within 30 post operative days ] [ Designated as safety issue: Yes ]
    Number and severity according to the Dindo classification (Ann Surg 240:205)

  • duration of medical leave [ Time Frame: up to 3 months after surgery ] [ Designated as safety issue: No ]
    data will be obtained from primary care physician

  • Continence [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]

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

    Score will be compared with pre-operative score.


  • Continence [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Wexner score

  • Continence [ Time Frame: 2 years after surgery ] [ Designated as safety issue: No ]

    Wexner score

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



Estimated Enrollment: 84
Study Start Date: July 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Stephan Bischofberger, MD    +41 71 858 1111    stephan.bischofberger@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

Additional Information:
No publications provided

Responsible Party: Lukas Marti, Oberarzt mbF (attending physician), Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01647763     History of Changes
Other Study ID Numbers: EKSG11/042
Study First Received: July 18, 2012
Last Updated: April 7, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Cantonal Hospital of St. Gallen:
Hemorrhoids

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

ClinicalTrials.gov processed this record on August 01, 2014