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

Symptomatic Haemorrhoidal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01038141
• Other study ID #: 583-07315a 1.2007.2484(REK)
• Status: Terminated
• Phase: N/A
• First received: December 22, 2009
• Last updated: July 29, 2014
• Start date: November 2009

Study information

• Verified date: June 2014
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Symptomatic Haemorrhoidal Disease

Intervention

Procedure:
• Surgery for advanced haemorrhoidal disease
Milligan Morgan vs Recto Anal Repair

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lorenskog

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of pain		up to 21 days	No
Secondary	Evaluation of sick leave		up to 21 days	No