Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy
NCT ID: NCT01647763
Last Updated: 2023-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2011-07-31
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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HAL/RAR
hemorrhoidal artery ligation with rectoanal repair
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.
Stapled hemorrhoidopexy
procedure for prolapse and hemorrhoids (PPH)
Resection using a circular stapler
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* inoperability with the assigned intervention, switching to other treatment method
18 Years
70 Years
ALL
No
Sponsors
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Cantonal Hospital of St. Gallen
OTHER
Responsible Party
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Lukas Marti
Leitender Arzt (attending surgeon)
Principal Investigators
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Lukas Marti, MD
Role: PRINCIPAL_INVESTIGATOR
Cantonal Hospital St. Gallen, Department of Surgery
Locations
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Kantonsspital Rorschach
_Rorschach, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Countries
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Related Links
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Website of the Department of Surgery (in German only)
Other Identifiers
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EKSG11/042
Identifier Type: -
Identifier Source: org_study_id
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