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

July 18, 2012
April 7, 2014
July 2011
December 2015   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01647763 on ClinicalTrials.gov Archive Site
  • 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).

Same as current
Not Provided
Not Provided
 
Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy
Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hemorrhoids
  • 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)
  • 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
  • Experimental: HAL/RAR
    hemorrhoidal artery ligation with rectoanal repair
    Intervention: Procedure: Hemorrhoidal artery ligation with rectoanal repair
  • Active Comparator: Stapled hemorrhoidopexy

    procedure for prolapse and hemorrhoids (PPH)

    Resection using a circular stapler

    Intervention: Procedure: Stapled hemorrhoidopexy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
84
December 2017
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Lukas Marti, MD +41 71 494 1339 lukas.marti@kssg.ch
Contact: Stephan Bischofberger, MD +41 71 494 1111
Switzerland
 
NCT01647763
EKSG11/042
No
Lukas Marti, Cantonal Hospital of St. Gallen
Cantonal Hospital of St. Gallen
Not Provided
Principal Investigator: Lukas Marti, MD Cantonal Hospital St. Gallen, Department of Surgery
Cantonal Hospital of St. Gallen
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP