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

Not Applicable

Terminated

• Conditions: Symptomatic Haemorrhoidal Disease
• Interventions: Procedure: Surgery for advanced haemorrhoidal disease

• Registration Number: NCT01038141
• Lead Sponsor: University Hospital, Akershus

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-23
• Primary Completion: 2013-09
• Status Verified: 2014-06
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Recto Anal Repair	Surgery for advanced haemorrhoidal disease	-
Milligan Morgan	Surgery for advanced haemorrhoidal disease	-

Primary Outcome Measures

Name	Time	Method
Evaluation of pain	up to 21 days

Secondary Outcome Measures

Name	Time	Method
Evaluation of sick leave	up to 21 days

Trial Locations

Locations (1)

Akershus University Hospital; 🇳🇴 Lorenskog, Norway