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

This study has been terminated.
(Due to lack of time.)
Sponsor:
Information provided by:
University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01038141
First received: December 22, 2009
Last updated: July 29, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Symptomatic Haemorrhoidal Disease
Procedure: Surgery for advanced haemorrhoidal disease

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recto Anal Repair or Milligan Morgans Operation of Grade 3 and 4 Symptomatic Haemorrhoidal Disease. A Prospective Randomized Controlled Study

Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • Evaluation of pain [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of sick leave [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: November 2009
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Milligan Morgan Procedure: Surgery for advanced haemorrhoidal disease
Milligan Morgan vs Recto Anal Repair
Other Names:
  • Transanal doppler-guided hemorrhoidal artery ligation.
  • Transanal hemorrhoidal dearterialization (THD).
Active Comparator: Recto Anal Repair Procedure: Surgery for advanced haemorrhoidal disease
Milligan Morgan vs Recto Anal Repair
Other Names:
  • Transanal doppler-guided hemorrhoidal artery ligation.
  • Transanal hemorrhoidal dearterialization (THD).

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038141

Locations
Norway
Akershus University Hospital
Lorenskog, Norway, 1478
Sponsors and Collaborators
University Hospital, Akershus
Investigators
Principal Investigator: Geir A Larsen, M.D., Ph.D. University Hospital, Akershus
  More Information

No publications provided

Responsible Party: Geir Arne Larsen, M.D., Ph.D., Akershus University Hospital
ClinicalTrials.gov Identifier: NCT01038141     History of Changes
Other Study ID Numbers: 583-07315a 1.2007.2484(REK)
Study First Received: December 22, 2009
Last Updated: July 29, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

ClinicalTrials.gov processed this record on August 28, 2014