Fecal Incontinence Clinical Trial
Official title:
Strategies for Predicting the Efficacy of Sacral Nerve Stimulation With Pelvic Floor Rehabilitation in the Management of Fecal Incontinence After Surgery of Anorectal Malformation.
NCT number | NCT05621629 |
Other study ID # | A333-3 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2022 |
Est. completion date | January 1, 2023 |
Verified date | April 2023 |
Source | Shengjing Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The posterior sagittal approach to anorectal malformation (ARM) has radically changed the outcome of these patients, improving the preservation of anal sphincters, owing to their anatomical identification. However, in long term follow-up, fecal incontinence and severe constipation remain the most frequent and disabling postoperative clinical problems, having a significant influence on quality of life. Current therapeutic measures for Fecal Incontinence include biofeedback, sacral nerve stimulation, radiofrequency energy delivery, surgical treatment and sphincter replacement. Biofeedback combined with SNS has achieved satisfactory results. However, not all patients have an improvement in their weakened anal sphincter and achieve acceptable continence. A detailed assessment of anorectal sphincter morphology and function can predict therapeutic outcome. Magnetic resonance imaging(MRI) can help to judge the anal atresia type, to display the presence and running of the fistula, and to show the nature of anal sphincter, such as the shape, thickness, directions and position of the anal sphincter complex and location in the pelvic floor and other systems malformations, finally to provide a reliable diagnostic basis for surgical program and prognostic assessment. High-resolution anorectal manometry (HR-ARM) is the latest internationally recognized examination for the evaluation of anorectal function. A standardised protocol of HR-ARM can characterise FI from dyssynergic or other neuromuscular and sensory problems. As a result, HR-ARM provides a more appropriate management in patients with FI. In order to assess whether patients with fecal incontinence should choose biofeedback therapy, our study included children with FI after anorectal malformation, and combined HR-ARM and MR to predict the efficacy of sacral nerve stimulation and pelvic floor rehabilitation.
Status | Completed |
Enrollment | 108 |
Est. completion date | January 1, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 18 Years |
Eligibility | Inclusion Criteria: 1.4-18 years old; 2.The voluntary or involuntary defecation in an inappropriate place during children's developmental age of 4 years or above; 3.Anorectal malformation, anal reconstruction surgery was performed immediately after birth, and at least two courses of biofeedback combined with SNS were experienced 4.Clinical data are complete and sphincter MR and anorectal manometry have been done. Exclusion Criteria: 1. Congenital and/or acquired intestinal diseases, such as congenital or severe secondary megacolon, intestinal stenosis, polyps, Crohn's disease, tuberculosis, inflammation, and tumours; 2. Neurological diseases, such as brain and spinal cord diseases, genetic metabolic diseases; 3. Psychosocial and behavioural diseases, and other systemic diseases; 4. Refused to MR and biofeedback combined with SNS. |
Country | Name | City | State |
---|---|---|---|
China | Shengjing Hospital | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Shengjing Hospital |
China,
Ambartsumyan L, Shaffer M, Carlin K, Nurko S. Comparison of longitudinal and radial characteristics of intra-anal pressures using 3D high-definition anorectal manometry between children with anoretal malformations and functional constipation. Neurogastroenterol Motil. 2021 Feb;33(2):e13971. doi: 10.1111/nmo.13971. Epub 2020 Sep 9. — View Citation
Bharucha AE, Rao SSC, Shin AS. Surgical Interventions and the Use of Device-Aided Therapy for the Treatment of Fecal Incontinence and Defecatory Disorders. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1844-1854. doi: 10.1016/j.cgh.2017.08.023. Epub 2017 Aug 22. — View Citation
Bischoff A, de La Torre L, Pena A. Comparative effectiveness of imaging modalities for preoperative assessment of anorectal malformation in the pediatric population. J Pediatr Surg. 2020 Feb;55(2):354. doi: 10.1016/j.jpedsurg.2019.09.078. Epub 2019 Oct 27. No abstract available. — View Citation
Bjorsum-Meyer T, Christensen P, Baatrup G, Jakobsen MS, Asmussen J, Qvist N. Magnetic resonance imaging of the anal sphincter and spine in patients with anorectal malformations after posterior sagittal anorectoplasty: a late follow-up cross-sectional study. Pediatr Surg Int. 2021 Jan;37(1):85-91. doi: 10.1007/s00383-020-04774-1. Epub 2020 Nov 3. — View Citation
Bjorsum-Meyer T, Christensen P, Jakobsen MS, Baatrup G, Qvist N. Correlation of anorectal manometry measures to severity of fecal incontinence in patients with anorectal malformations - a cross-sectional study. Sci Rep. 2020 Apr 7;10(1):6016. doi: 10.1038/s41598-020-62908-w. — View Citation
Brisighelli G, Macchini F, Consonni D, Di Cesare A, Morandi A, Leva E. Continence after posterior sagittal anorectoplasty for anorectal malformations: comparison of different scores. J Pediatr Surg. 2018 Sep;53(9):1727-1733. doi: 10.1016/j.jpedsurg.2017.12.020. Epub 2017 Dec 27. — View Citation
Brown HW, Dyer KY, Rogers RG. Management of Fecal Incontinence. Obstet Gynecol. 2020 Oct;136(4):811-822. doi: 10.1097/AOG.0000000000004054. — View Citation
Divarci E, Ergun O. General complications after surgery for anorectal malformations. Pediatr Surg Int. 2020 Apr;36(4):431-445. doi: 10.1007/s00383-020-04629-9. Epub 2020 Feb 21. — View Citation
Koppen IJN, Vriesman MH, Saps M, Rajindrajith S, Shi X, van Etten-Jamaludin FS, Di Lorenzo C, Benninga MA, Tabbers MM. Prevalence of Functional Defecation Disorders in Children: A Systematic Review and Meta-Analysis. J Pediatr. 2018 Jul;198:121-130.e6. doi: 10.1016/j.jpeds.2018.02.029. Epub 2018 Apr 12. — View Citation
Loganathan AK, Mathew AS, Kurian JJ. Assessment of Quality of Life and Functional Outcomes of Operated Cases of Hirschsprung Disease in a Developing Country. Pediatr Gastroenterol Hepatol Nutr. 2021 Mar;24(2):145-153. doi: 10.5223/pghn.2021.24.2.145. Epub 2021 Mar 4. — View Citation
Rajindrajith S, Devanarayana NM, Thapar N, Benninga MA. Functional Fecal Incontinence in Children: Epidemiology, Pathophysiology, Evaluation, and Management. J Pediatr Gastroenterol Nutr. 2021 Jun 1;72(6):794-801. doi: 10.1097/MPG.0000000000003056. — View Citation
Sulkowski JP, Nacion KM, Deans KJ, Minneci PC, Levitt MA, Mousa HM, Alpert SA, Teich S. Sacral nerve stimulation: a promising therapy for fecal and urinary incontinence and constipation in children. J Pediatr Surg. 2015 Oct;50(10):1644-7. doi: 10.1016/j.jpedsurg.2015.03.043. Epub 2015 Mar 26. — View Citation
Yates G, Friedmacher F, Cleeve S, Athanasakos E. Anorectal manometry in pediatric settings: A systematic review of 227 studies. Neurogastroenterol Motil. 2021 Apr;33(4):e14006. doi: 10.1111/nmo.14006. Epub 2020 Oct 28. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average anal resting pressure | Average maximum pressure (mm Hg) over the functional anal canal length during the 30-s period of rest | Baseline (Before treatment) | |
Primary | Maximum anal squeeze pressure | Maximum pressure (mm Hg) sustained over the duration of the 5-s squeeze maneuver | Baseline (Before treatment) | |
Primary | Functional anal canal length (FACL) | Length of anal canal (cm) in which pressure exceeded rectal pressure by >5 mm Hg | Baseline (Before treatment) | |
Primary | Thickness of the external anal sphincter | Three measurements were made laterally for the external anal sphincter where the muscle appeared thickest during sphincter MRI , and an average value was determined. | Baseline (Before treatment) | |
Primary | Thickness of the internal anal sphincter | The thickness of the internal anal sphincter was measured three times at a centimeter above the external sphincter during sphincter MRI. | Baseline (Before treatment) | |
Primary | Whether the rectum passes through the center of puborectalis | Whether the rectum crosses the center of the puborectalis muscle on sphincter MRI. | Baseline (Before treatment) | |
Primary | Pena's questionnaires score after treatment | select the pena questionnaire to assess bowel function in patients with fecal incontinence after anorectal malformation after treatment. | at the end of 4-weeks Biofeedback combined with SNS treatment | |
Primary | Pena's questionnaires score before treatment | select the pena questionnaire to assess bowel function in patients with fecal incontinence after anorectal malformation before treatment. | Baseline (Before treatment) |
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