Clinical trial NCT03746834: NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation
Official title: NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fecal Incontinence
Anorectal Malformation
Keywords: Fecal incontinence
Anorectal malformation
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients are treated with injection of NASHA/Dx and act as their own Controls over time.
Primary purpose: TREATMENT

Brief summary: Persistent fecal incontinence (FI) after anorectal malformations (ARM) is a common occurence. During the last two decades perianal injection therapy has emerged as an option for treating patients with FI due to other causes than ARMs. The studies done on different implants have always expempted patients with ARM which has led to ARM being a formal contraindication for treatment with perianal injection therapy.

The study aims to treat patients with persistent FI after ARM with perianal injection of NASHA/Dx (Solesta®) and follow them with Clinical examination and questionnaires up to 18 months post treatment.


Eligibility criteria: Inclusion Criteria:

* Persistent FI (Miller incontinence score \>5)
* Anorectal malformation.

Exclusion Criteria:

* Pregnancy
* Rectal prolapse
* Significant mucosal prolapse
* Inflammatory bowel disease
* Anorectal surgery within the last year Before inclusion
* Anticoagulant medication/bleeding diathesis
* Anorectal sepsis in the past
* Immunodeficiency
* Immunosuppressing therapy

Primary outcomes:
measure: Change in number of incontinence episodes
timeFrame: The change in number of incontinence episodes before treatment is compared with data at 18 months after injection.
Secondary outcomes:
measure: Miller´s incontinence score
timeFrame: Before treatment compared with data at 18 months after treatment. Miller´s incontinence score is measured on a scale from 0 (meaning total fecal continence) to 18 (meaning total fecal incontinence).
measure: Quality of life, general
timeFrame: Before treatment compared with data at 18 months after treatment. SF-36 measures quality of life in 8 subscales. Each scaled from 0 to 100. Higher score is considered better. Two total scores of mental and physical QoL can be calculated.
measure: Adverse events
timeFrame: Before treatment compared with data at 18 months after treatment
measure: Quality of life, disease specific
timeFrame: Before treatment compared with data at 18 months after treatment. Measures 4 subscales, each measuring 1-4. Higher score implies better quality of life.
Other outcomes:
Locations:
Study officials:
References:
citation: Danielson J, Karlbom U, Wester T, Graf W. Efficacy and quality of life 2 years after treatment for faecal incontinence with injectable bulking agents. Tech Coloproctol. 2013 Aug;17(4):389-95. doi: 10.1007/s10151-012-0949-8. Epub 2012 Dec 7.
citation: Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum. 2009 Jun;52(6):1101-6. doi: 10.1007/DCR.0b013e31819f5cbf.
citation: Danielson J, Karlbom U, Graf W, Wester T. Outcome in adults with anorectal malformations in relation to modern classification - Which patients do we need to follow beyond childhood? J Pediatr Surg. 2017 Mar;52(3):463-468. doi: 10.1016/j.jpedsurg.2016.10.051. Epub 2016 Nov 15.