Clinical trial NCT01038141: Recto Anal Repair or Milligan Morgans Operation of Grade 3 and 4 Symptomatic Haemorrhoidal Disease
Official title: Recto Anal Repair or Milligan Morgans Operation of Grade 3 and 4 Symptomatic Haemorrhoidal Disease. A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Symptomatic Haemorrhoidal Disease
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of pain
timeFrame: up to 21 days
Secondary outcomes:
measure: Evaluation of sick leave
timeFrame: up to 21 days
Other outcomes:
Locations:
city: Lorenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: University Hospital, Akershus
name: Geir A Larsen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: