Management of FI After Surgery of ARM
Study Details
Study Description
Brief Summary
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.
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Detailed Description
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, with an important impact on quality of life. A cluster of physical and psychological problems appear in pediatric patients, including repeated infections, skin ulcer and scar, social anxiety disorder, behavioral problems, self-abasement or isolation and other problems, which cause children full of guilt and embarrassment and increase the risk of bullying.
Current therapeutic measures for FI include biofeedback, sacral nerve stimulation, radiofrequency energy delivery , surgical treatment, and sphincter replacement. Zhengwei Yuan et al. conducted a follow-up study on 31 patients with FI after ARM, and confirmed that biofeedback combined with SNS has a good effect on patients with FI after ARM. However,not all patients improve their impaired anal sphincter and acquire satisfactory continence. A lot of time and treatment costs are wasted. Therefore, it is necessary to clarify the indications for the application of biofeedback combined with SNS.
Severity of ARM affects the degree of development of internal and external anal sphincters. A detailed assessment of anorectal sphincter morphology and function can predict therapeutic outcome. In clinical practice, endoanal ultrasound and endoanal magnetic resonance imaging (MRI) are the main imaging modalities for the anatomical assessment of the anal sphincter complex. Sphincter MR is more suitable for observing the nature of the anal sphincter such as the shape, thickness, directions, and position of the anal sphincter complex and its location on the pelvic floor. MR examination has a high clinical value in the diagnosis of ARM. It can help determine the anal atresia type, display the presence and running of the fistula, evaluate the perianal muscle development and other systems' malformations, and finally provide a reliable diagnostic basis for surgical program and prognostic assessment. The role of MR is similar to that of EUS in some aspects. However, the sphincter MRI can clearly demonstrate the sphincter pattern, the position of the sphincter on the pelvic floor, and several indicators that cannot be detected by EUS. 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.Therefore, HR-ARM provides a more appropriate management in patients with FI. The anorectal manometry is a functional study that can evaluate the potential for muscular sphincterial recovery after BFB; the assessment derives greater benefit also from a morphological evaluation (MRI) in particular when the manometry is unfavorable.
The study included children with FI after ARM, and the investigators combined HR-ARM and MR to predict the efficacy of sacral nerve stimulation and pelvic floor rehabilitation to determine whether patients with fecal incontinence should choose biofeedback therapy.
Study Design
Outcome Measures
Primary Outcome Measures
- Average anal resting pressure [Baseline (Before treatment)]
Average maximum pressure (mm Hg) over the functional anal canal length during the 30-s period of rest
- Maximum anal squeeze pressure [Baseline (Before treatment)]
Maximum pressure (mm Hg) sustained over the duration of the 5-s squeeze maneuver
- Functional anal canal length (FACL) [Baseline (Before treatment)]
Length of anal canal (cm) in which pressure exceeded rectal pressure by >5 mm Hg
- Thickness of the external anal sphincter [Baseline (Before treatment)]
Three measurements were made laterally for the external anal sphincter where the muscle appeared thickest during sphincter MRI , and an average value was determined.
- Thickness of the internal anal sphincter [Baseline (Before treatment)]
The thickness of the internal anal sphincter was measured three times at a centimeter above the external sphincter during sphincter MRI.
- Whether the rectum passes through the center of puborectalis [Baseline (Before treatment)]
Whether the rectum crosses the center of the puborectalis muscle on sphincter MRI.
- Pena's questionnaires score after treatment [at the end of 4-weeks Biofeedback combined with SNS treatment]
select the pena questionnaire to assess bowel function in patients with fecal incontinence after anorectal malformation after treatment.
- Pena's questionnaires score before treatment [Baseline (Before treatment)]
select the pena questionnaire to assess bowel function in patients with fecal incontinence after anorectal malformation before treatment.
Eligibility Criteria
Criteria
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:
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Congenital and/or acquired intestinal diseases, such as congenital or severe secondary megacolon, intestinal stenosis, polyps, Crohn's disease, tuberculosis, inflammation, and tumours;
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Neurological diseases, such as brain and spinal cord diseases, genetic metabolic diseases;
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Psychosocial and behavioural diseases, and other systemic diseases;
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Refused to MR and biofeedback combined with SNS.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shengjing Hospital | Shenyang | Liaoning | China | 110004 |
Sponsors and Collaborators
- Shengjing Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Brown HW, Dyer KY, Rogers RG. Management of Fecal Incontinence. Obstet Gynecol. 2020 Oct;136(4):811-822. doi: 10.1097/AOG.0000000000004054.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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