Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05621629
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2022-08-28
Brief Title:
Management of FI After Surgery of ARM
Sponsor:
Shengjing Hospital
Organization:
Shengjing Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 imagingMRI 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
A detailed assessment of anorectal sphincter morphology and function can predict therapeutic outcome Magnetic resonance imagingMRI 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
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 Howevernot 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 problemsTherefore 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
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 Howevernot 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 problemsTherefore 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None