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