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

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

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.

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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.

Conditions

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Symptomatic Haemorrhoidal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Milligan Morgan

Group Type ACTIVE_COMPARATOR

Surgery for advanced haemorrhoidal disease

Intervention Type PROCEDURE

Milligan Morgan vs Recto Anal Repair

Recto Anal Repair

Group Type ACTIVE_COMPARATOR

Surgery for advanced haemorrhoidal disease

Intervention Type PROCEDURE

Milligan Morgan vs Recto Anal Repair

Interventions

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Surgery for advanced haemorrhoidal disease

Milligan Morgan vs Recto Anal Repair

Intervention Type PROCEDURE

Other Intervention Names

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Transanal doppler-guided hemorrhoidal artery ligation. Transanal hemorrhoidal dearterialization (THD).

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No