Status:
SUSPENDED
Medical and Economic Evaluation of a Magnetic Anal Sphincter for Patients With Severe Anal Incontinence
Lead Sponsor:
Nantes University Hospital
Conditions:
Fecal Incontinence
Anal Incontinence
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to compare 2 surgical treatments of severe fecal incontinence (defined as more than a major leak per week). The hypothesis of this "non-inferiority" trial is that magnetic...
Detailed Description
Severe anal incontinence, defined as the uncontrolled passing of stool at least once a week, is a problem that has a serious impact on the quality of life. In the event of failure of conservative trea...
Eligibility Criteria
Inclusion
- Adult patient (male or female) of 18 to 75 years of age
- Affected by severe anal incontinence (SAI)\*.
- Documented failure of conservative treatment (reeducation and medical treatment)
- With functional anal sphincter\*\*
- Agrees to take part in the study and has signed the informed consent form
- Agrees to undergo post-operative surveillance for a period of one (1) year
- Covered by National Insurance
- Defined as follows: at least one involuntary passing of stool per week measured by collecting data on incontinence accidents on a 3-week stool record chart, with the continence problem developing over more than 6 months. \*\*Defined as follows: external sphincter intact (without injury or after sphincter repair) or external sphincter altered, with an injury of a size that does not justify sphincter repair.
- Internal sphincter injuries not taken into account (by professional consensus).
Exclusion
- Anorectal or pelvic malformations
- Local conditions incompatible with the proposed sizes of the MAS (extreme obesity, thickness of the tissue in the anorectal area)
- Sequelae of rectal resections - presence of cancer of the rectum or anus
- Rectal prolapse and/or major pelvic floor disorders
- Major chronic disorder of the intestinal motility, irritable bowel syndrome, repeated faecalomas, megarectum
- Extensive sphincter degeneration
- Consequences of radiation-induced rectitis and chronic inflammatory diseases of the bowel (Crohn's disease)
- Neurological disorders or systemic diseases (multiple sclerosis, scleroderma, paraplegia)
- Festering sores of the perineal and/or anorectal regions
- Known or suspected risks of allergy to titanium
- Active pelvic infection
- Contraindications to SNS:
- Cardiac stimulator or defibrillator implant
- Malformation of the sacrum
- Patient exposed to Magnetic Resonance Imaging
- Skin diseases exposing the patient to the risk of infection (at the investigator's discretion)
- Patient scheduled for diathermy or ablation by radiofrequency
- Pregnant women
- Adults under guardianship
- Patients involved in a mobility project in the year following the operation
- Patient already subjected to one or other of the therapeutic approaches (MAS or SNS) Please note: coagulation problems (including anti-aggregant or anti-coagulant treatments) are not a contraindication if these problems can be corrected during the perioperative period.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01920607
Start Date
November 1 2013
End Date
August 1 2017
Last Update
June 26 2017
Active Locations (1)
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1
Nantes University Hospital
Nantes, France, 4000