Recto Anal Repair or Milligan Morgans Operation of Grade 3 and 4 Symptomatic Haemorrhoidal Disease

Study Overview
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Brief Summary
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The purpose of this study is to compare a new mini invasive surgical procedure (Recto Anal Repair) to the traditional Milligan-Morgan procedure in patients suffering from severe piles.

Detailed Description
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An estimated 4% of the adult population suffers from haemorrhoidal disease. In 1937 E. T. Milligan and C. N. Morgan described a method for operating piles that still is regarded the gold standard in the treatment of severe haemorrhoidal disease. This procedure is followed by a prolonged and painful recovery. To overcome the long recovery often combined with long sick leaves, less invasive methods for treating piles have been introduced during the last decade. However, few studies have compared patient benefits and the long term outcome of these techniques, and the choice of treatment is often based on the skills and experience of the individual surgeon. A new and promising mini invasive approach utilizes doppler-guided ligation of the haemorrhoidal arteries. All haemorrhoidal arteries are identified and then ligated approximately 2 cm above the anal canal. Thereafter the rectal mucosa with the piles is repositioned and fixed in the rectum with running sutures. This procedure is termed Recto Anal Repair (RAR) and leads to shrinking of the piles and restored anatomy of the anus and the rectum. The investigators want to execute a randomized, consecutive, prospective, controlled study with long term follow up to compare the RAR procedure to Milligans operation for the treatment of severe haemorrhoidal disease. The primary goals are evaluation of pain and sick leave 7, 14 and 21 days after surgery and reported reduction of pile symptoms after 3, 6 and 12 months. In addition the investigators want to compare the overall satisfaction with the two procedures.

Official Title
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Recto Anal Repair or Milligan Morgans Operation of Grade 3 and 4 Symptomatic Haemorrhoidal Disease. A Prospective Randomized Controlled Study

Conditions
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Symptomatic Haemorrhoidal Disease

Intervention / Treatment
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* Procedure: Surgery for advanced haemorrhoidal disease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic grade 3 and 4 haemorrhoidal disease Age 18-80 Patients who are fitted for local and general anaesthesia Patients who are able to understand the information given and are willing to give a written consent Exclusion Criteria: Previous operated for piles Previous operated in the anal canal Faecal incontinence Inflammatory bowel disease with affection of the anal canal Chronic diarrhea Fissura ani Fistula in ano Chronic anal pain Neurological illness with affection of anal sensation Patients not able to follow the study protocol Patients taking immunosuppressant medication Pregnancy Disability Anal polyps Medication affecting the coagulation system Circular anal prolapse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Milligan Morgan<br> | Procedure: Surgery for advanced haemorrhoidal disease<br>* Milligan Morgan vs Recto Anal Repair<br>* Other names: Transanal hemorrhoidal dearterialization (THD).;|
| Active Comparator: Recto Anal Repair<br> | Procedure: Surgery for advanced haemorrhoidal disease<br>* Milligan Morgan vs Recto Anal Repair<br>* Other names: Transanal hemorrhoidal dearterialization (THD).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pain |  | up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of sick leave |  | up to 21 days |