Fecal Incontinence Clinical Trial
— MOS STICOfficial title:
Medical and Economic Evaluation of a Magnetic Anal Sphincter for Patients With Severe Anal Incontinence
Verified date | June 2017 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 anal sphincter is clinically as effective as SNS, but more cost-effective in managing fecal incontinence
Status | Suspended |
Enrollment | 71 |
Est. completion date | August 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
France | Nantes University Hospital | Nantes |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Wong MT, Meurette G, Wyart V, Lehur PA. Does the magnetic anal sphincter device compare favourably with sacral nerve stimulation in the management of faecal incontinence? Colorectal Dis. 2012 Jun;14(6):e323-9. doi: 10.1111/j.1463-1318.2012.02995.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average number of fecal incontinence episodes | Average number of fecal incontinence episodes per week over a period of 3 weeks, 6 months after the implantation of a magnetic anal sphincter (FenixTM magnetic anal sphincter group) or of the Spinelli electrode during the PNE test (sacral nerve stimulation group), on the basis of a standardised stool diary | 6 months | |
Secondary | Overall cost for the health care system | Overall cost for the health care system including implantation and follow-up - Duration and cost of hospital admissions,- Cost of covering any complications arising | 12 months | |
Secondary | Respective complications of the two therapeutic approaches | Number and nature of the complications over 12 months, according to the Clavien-Dindo classification | 12 months | |
Secondary | Functional results at 6 and 12 months, compared with baseline | Stool record chart, faecal incontinence score (Wexner), recourse to antidiarrhoeal treatment, the taking of analgesics, constipation score (ODS), recourse to a treatment for constipation | Baseline, 6 & 12 months | |
Secondary | Quality of life and overall satisfaction | Quality of life and overall satisfaction of the patient at 6 and 12 months, compared with baseline:Quality of life score specific to faecal incontinence (FIQL), General quality of life scores (SF 36 and EQ-5D) | Baselnie, 6 & 12 months | |
Secondary | Anorectal manometry data | Sphincter pressure at rest, voluntary contractions, rectal maximum tolerable volume. | Baseline & 6 months |
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