Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

Cantonal Hospital of St. Gallen

Status: Active, not recruiting

Conditions: Hemorrhoids

Treatments: Procedure: Hemorrhoidal artery ligation with rectoanal repair; Procedure: Stapled hemorrhoidopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT01647763

EKSG11/042

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

HAL/RAR

Experimental group

Description:

hemorrhoidal artery ligation with rectoanal repair

Treatment:

Procedure: Hemorrhoidal artery ligation with rectoanal repair

Stapled hemorrhoidopexy

Active Comparator group

Description:

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

Treatment:

Procedure: Stapled hemorrhoidopexy