An interventional study of Surgery for advanced haemorrhoidal disease in Symptomatic Haemorrhoidal Disease, sponsored by University Hospital, Akershus. Terminated at 1 site in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-07-30.
Sponsored by University Hospital, Akershus · Not applicable, Interventional, and Treatment
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.
University Hospital, Akershus is the lead sponsor of 123 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Surgery for advanced haemorrhoidal disease
Procedure: Surgery for advanced haemorrhoidal disease
Milligan Morgan vs Recto Anal Repair
Also known as: Transanal doppler-guided hemorrhoidal artery ligation., Transanal hemorrhoidal dearterialization (THD).
Evaluation of pain
Time frame: up to 21 days
Evaluation of sick leave
Time frame: up to 21 days
This study is terminated, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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University Hospital, Akershus