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TerminatedNCT01038141Updated Jul 30, 2014

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

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

Why this study was terminated
Due to lack of time.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Symptomatic Haemorrhoidal Disease
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Milligan Morgan

    Procedure: Surgery for advanced haemorrhoidal disease

  • Active comparator
    Recto Anal Repair

    Procedure: Surgery for advanced haemorrhoidal disease

Interventions

  • ProcedureSurgery for advanced haemorrhoidal disease

    Milligan Morgan vs Recto Anal Repair

    Also known as: Transanal doppler-guided hemorrhoidal artery ligation., Transanal hemorrhoidal dearterialization (THD).

06

What researchers measure

Primary outcomes

  1. Evaluation of pain

    Time frame: up to 21 days

Secondary outcomes

  1. Evaluation of sick leave

    Time frame: up to 21 days

07

Study locations

1 site
  • Akershus University Hospital
    Lorenskog, 1478, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01038141
Lead sponsor
University Hospital, Akershus
First posted
Dec 23, 2009
Start date
Nov 2009
Primary completion
Sep 2013
Last update
Jul 30, 2014

Study contacts

Geir A Larsen, M.D., Ph.D.
principal investigator · University Hospital, Akershus

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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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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