Management of FI After Surgery of ARM

NCT05621629 | Completed

• 1 other identifier: A333-3
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence; Childhood ALL; Anorectal Malformations

Outcome Measures

Primary Outcomes (8)

• 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)

• Maximum anal squeeze pressure

  Maximum pressure (mm Hg) sustained over the duration of the 5-s squeeze maneuver

  Baseline (Before treatment)

• Functional anal canal length (FACL)

  Length of anal canal (cm) in which pressure exceeded rectal pressure by \>5 mm Hg

  Baseline (Before treatment)

• 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)

• 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)

• 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)

• 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

• 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)

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Fecal Incontinence after surgery of Anorectal Malformation

You may qualify if:

• 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.

You may not qualify if:

• Congenital and/or acquired intestinal diseases, such as congenital or severe secondary megacolon, intestinal stenosis, polyps, Crohn's disease, tuberculosis, inflammation, and tumours;
• Neurological diseases, such as brain and spinal cord diseases, genetic metabolic diseases;
• Psychosocial and behavioural diseases, and other systemic diseases;
• Refused to MR and biofeedback combined with SNS.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

Related Publications (14)

• 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.

  PMID: 33833970 BACKGROUND

• 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.

  PMID: 33534361 BACKGROUND

• 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.

  PMID: 28838787 BACKGROUND

• 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.

  PMID: 32086570 BACKGROUND

• 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.

  PMID: 25858097 BACKGROUND

• Brown HW, Dyer KY, Rogers RG. Management of Fecal Incontinence. Obstet Gynecol. 2020 Oct;136(4):811-822. doi: 10.1097/AOG.0000000000004054.

  PMID: 32925633 BACKGROUND

• 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.

  PMID: 33141917 BACKGROUND

• 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.

  PMID: 31718867 BACKGROUND

• 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.

  PMID: 32902923 BACKGROUND

• 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.

  PMID: 32265467 BACKGROUND

• 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.

  PMID: 33118295 BACKGROUND

• 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.

  PMID: 29656863 BACKGROUND

• 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.

  PMID: 29370894 BACKGROUND

• Shen ZY, Zhang Y, Tao CH, Wang DJ, Zhang ZB, Zhang SC. A Predictive Model to Identify the Effects of Transcutaneous Sacral Nerve Stimulation With Pelvic Floor Exercises in Fecal Incontinence After Surgery for Anorectal Malformation. Am J Gastroenterol. 2024 Jan 1;119(1):191-199. doi: 10.14309/ajg.0000000000002544. Epub 2023 Oct 3.

  PMID: 37787428 DERIVED

MeSH Terms

Conditions

Fecal Incontinence; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Anorectal Malformations

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: November 18, 2022
• Study Start: September 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

CN (1)