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Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

Primary Purpose

Hemorrhoids

Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hemorrhoidal artery ligation with rectoanal repair
Stapled hemorrhoidopexy
Sponsored by
Cantonal Hospital of St. Gallen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring Hemorrhoids

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kantonsspital Rorschach
  • Kantonsspital St. Gallen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HAL/RAR

Stapled hemorrhoidopexy

Arm Description

hemorrhoidal artery ligation with rectoanal repair

procedure for prolapse and hemorrhoids (PPH) Resection using a circular stapler

Outcomes

Primary Outcome Measures

Pain POD1
Visual analogue scale (VAS). Additionally recording of the pain medication used.

Secondary Outcome Measures

Pain after 8h
Measuring post operative pain using the visual analogue scale (0 - 10). Additionally recording of the pain medication used.
Pain 30d
visual analogue scale
Pain 1y
visual analogue scale
Pain 2y
visual analogue scale
post operative surgical complications
Number and severity according to the Dindo classification (Ann Surg 240:205)
duration of medical leave
data will be obtained from primary care physician
Continence 30d
Physician obtains data to calculate the Wexner Score (Dis Colon Rectum 36:77). Score will be compared with pre-operative score.
Continence 1y
Wexner score
Continence 2y
Wexner score Additionally anorectal manometry (results will be compared with pre-operative data).

Full Information

First Posted
July 18, 2012
Last Updated
August 7, 2023
Sponsor
Cantonal Hospital of St. Gallen
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1. Study Identification

Unique Protocol Identification Number
NCT01647763
Brief Title
Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy
Official Title
Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2011 (Actual)
Primary Completion Date
December 2022 (Actual)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital of St. Gallen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HAL/RAR
Arm Type
Experimental
Arm Description
hemorrhoidal artery ligation with rectoanal repair
Arm Title
Stapled hemorrhoidopexy
Arm Type
Active Comparator
Arm Description
procedure for prolapse and hemorrhoids (PPH) Resection using a circular stapler
Intervention Type
Procedure
Intervention Name(s)
Hemorrhoidal artery ligation with rectoanal repair
Other Intervention Name(s)
HAL (hemorrhoidal artery ligation), RAR (rectoanal repair)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stapled hemorrhoidopexy
Other Intervention Name(s)
Longo procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain POD1
Description
Visual analogue scale (VAS). Additionally recording of the pain medication used.
Time Frame
between 6:00 am and 8:00 am the day after surgery
Secondary Outcome Measure Information:
Title
Pain after 8h
Description
Measuring post operative pain using the visual analogue scale (0 - 10). Additionally recording of the pain medication used.
Time Frame
8 hours after surgery
Title
Pain 30d
Description
visual analogue scale
Time Frame
30 days after surgery
Title
Pain 1y
Description
visual analogue scale
Time Frame
1 year after surgery
Title
Pain 2y
Description
visual analogue scale
Time Frame
2 years after surgery
Title
post operative surgical complications
Description
Number and severity according to the Dindo classification (Ann Surg 240:205)
Time Frame
within 30 post operative days
Title
duration of medical leave
Description
data will be obtained from primary care physician
Time Frame
up to 3 months after surgery
Title
Continence 30d
Description
Physician obtains data to calculate the Wexner Score (Dis Colon Rectum 36:77). Score will be compared with pre-operative score.
Time Frame
30 days after surgery
Title
Continence 1y
Description
Wexner score
Time Frame
1 year after surgery
Title
Continence 2y
Description
Wexner score Additionally anorectal manometry (results will be compared with pre-operative data).
Time Frame
2 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukas Marti, MD
Organizational Affiliation
Cantonal Hospital St. Gallen, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Rorschach
City
_Rorschach
ZIP/Postal Code
9400
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.chirurgie.kssg.ch/home/unsere_klinik/Leistungsangebot_standort_st_gallen/koloproktologie.html
Description
Website of the Department of Surgery (in German only)

Learn more about this trial

Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

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