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

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

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.

Study Overview

• Status: Terminated
• Conditions: Symptomatic Haemorrhoidal Disease
• Intervention / Treatment: Procedure: Surgery for advanced haemorrhoidal disease

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Lorenskog, Norway, 1478
    • Akershus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Milligan Morgan	Procedure: Surgery for advanced haemorrhoidal disease; Milligan Morgan vs Recto Anal Repair; Other Names: Transanal doppler-guided hemorrhoidal artery ligation.; Transanal hemorrhoidal dearterialization (THD).
Active Comparator: Recto Anal Repair	Procedure: Surgery for advanced haemorrhoidal disease; Milligan Morgan vs Recto Anal Repair; Other Names: Transanal doppler-guided hemorrhoidal artery ligation.; Transanal hemorrhoidal dearterialization (THD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of pain	up to 21 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Investigators: Principal Investigator: Geir A Larsen, M.D., Ph.D., University Hospital, Akershus

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: December 22, 2009
• First Submitted That Met QC Criteria: December 22, 2009
• First Posted (Estimate): December 23, 2009

Study Record Updates

• Last Update Posted (Estimate): July 30, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 583-07315a 1.2007.2484(REK)