Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

Study Overview
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Brief Summary
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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.

Official Title
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Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

Conditions
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Hemorrhoids

Intervention / Treatment
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* Procedure: Hemorrhoidal artery ligation with rectoanal repair
* Procedure: Stapled hemorrhoidopexy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HAL/RAR<br>hemorrhoidal artery ligation with rectoanal repair | Procedure: Hemorrhoidal artery ligation with rectoanal repair<br>* 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.<br>* Other names: RAR (rectoanal repair);|
| Active Comparator: Stapled hemorrhoidopexy<br>procedure for prolapse and hemorrhoids (PPH) Resection using a circular stapler | Procedure: Stapled hemorrhoidopexy<br>* 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.<br>* Other names: Longo procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain POD1 | Visual analogue scale (VAS). Additionally recording of the pain medication used. | between 6:00 am and 8:00 am the day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after 8h | Measuring post operative pain using the visual analogue scale (0 - 10). Additionally recording of the pain medication used. | 8 hours after surgery | 
| Pain 30d | visual analogue scale | 30 days after surgery | 
| Pain 1y | visual analogue scale | 1 year after surgery | 
| Pain 2y | visual analogue scale | 2 years after surgery | 
| post operative surgical complications | Number and severity according to the Dindo classification (Ann Surg 240:205) | within 30 post operative days | 
| duration of medical leave | data will be obtained from primary care physician | up to 3 months after surgery | 
| Continence 30d | Physician obtains data to calculate the Wexner Score (Dis Colon Rectum 36:77). Score will be compared with pre-operative score. | 30 days after surgery | 
| Continence 1y | Wexner score | 1 year after surgery | 
| Continence 2y | Wexner score Additionally anorectal manometry (results will be compared with pre-operative data). | 2 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhoids