Bowel DysfunctionNCT05716230
Bowel Function and Associated Risk Factors for Bowel Dysfunciton in Patients With Anorectal Malformation
An observational study of Bowel Dysfunction, run by Nanjing Children's Hospital at 1 site in China.
Trial summary
The present study was designed to evaluate bowel function in preschool and early childhood in a large number of patients with anorectal Malformation and to identify the associated risk factors for bowel dysfunction. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Bowel Dysfunction
- What is being tested?
- bowel function score questionnaire survey
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2022to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with ARM who were performed with surgery.The follow-up age was more than 4 years old.
Who may be able to join
- Anorectal malformation >4 years old
Who cannot join
- Down syndrome patients <4 years
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210008
Changgui Lu, 13770848448, luchanggui1984@163.com
About this study
Official title: Bowel Function and Associated Risk Factors for Bowel Dysfunciton in Preschool and Early Childhood in Patients With Anorectal Malformation
The present study was designed to evaluate bowel function in preschool and early childhood in a large number of patients with anorectal Malformation and to identify the associated risk factors for bowel dysfunction.
Read the detailed description
Anorectal malformation (ARM) is a type of congenital malformation resulting from post-embryonic intestinal dysgenesis, occurring in about 1 in 5000 cases.Surgery is an effective means of treating ARM,which includes reconstruction of the anus and treatment of associated deformities. However, even with reconstruction of the anus, most children still have serious complications, such as constipation, fecal incontinence, urinary incontinence, and sexual dysfunction, in the mid-to-long postoperative period.A lot of studies have been designed to explore the trend toward normal bowel habits from preschool and early childhood age to adolescence or adult; however, no apparent improvement in bowel habits was completely confirmed. In contrast, many reports have shown that poor bowel function in preschool and early childhood may lead to social problems and depression in adolescence and adult.The reasons for bowel dysfunction of ARM in preschool and early childhood were complicated and undefined,including associated malformations, the type of ARM, and the development of the perianal sphincter,etc.The bowel function score (BFS) is currently used to assess mid- and long-term anal function in patients with ARM, and comprises seven major categories (e.g., self-perception, fecal control, stool collection, and social problems) with a total of 20 points, or less than 17 points, for the presence of anal weakness (11-17 points, for the general weakness, or less than 11 points, for the severe weakness) .Therefore,bowel function at preschool and early childhood should be evaluated in a large number of patients with ARM and the associated risk factors for bowel dysfunction should also be assessed. The present study was designed to evaluate bowel function in preschool and early childhood in a large number of patients with ARM and to identify the associated risk factors for bowel dysfunction using BFS.
- Conditions
- Bowel Dysfunction
- Being tested
- bowel function score questionnaire survey
- Keywords
- anorectal malformation, Bowel function, risk factors
- Medical subject headings
- Intestinal Diseases, Anorectal Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bowel function score questionnaire surveyOther
Bowel function score(BFS, total 20 points) was approved by Rintala in 1995, and patients with a score ≥ 17 were considered to have normal bowel habits. 7 items were in BFS, including the ability to hold back defecation, feeling/reporting the urge to defecate, frequency of defecation, soiling, accidents, constipation. In December 2022, BFS questionnaire surveys were conducted on children with ARM who underwent surgical repair between January 2017 and December 2019 at Children's Hospital of Nanjing Medical University.
What is being measured
The primary outcome is the main question the study is designed to answer.
bowel function score in partipants with ARM
approved by Rintala in 1995, and patients with a score ≥ 17 were considered to have normal bowel habits
Measured: through study completion, an average of 6 year
Secondary outcomes (1)
Sacral ratio in partipants with ARM
test by X ray
Measured: through study completion, an average of 6 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start20 Nov 2022
- Primary completion29 Jan 2023
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weibing Tang, Nanjing Children's Hospital
- Investigators
- Weibing Tang, Dr, Study director, Children's Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716230
- Sponsor's protocol ID
- NanjingCH0109
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu C, Pan S, Chen H, Tang W. Bowel function and features of bowel dysfunction in preschool children with anorectal malformation type rectoperineal and rectovestibular fistula. Eur J Pediatr. 2024 Feb;183(2):599-610. doi: 10.1007/s00431-023-05306-4. Epub 2023 Nov 8.
PubMed 37935997
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Function and Associated Risk Factors for Bowel Dysfunciton in Preschool and Early Childhood in Patients With Anorectal Malformation
- ClinicalTrials.gov ID
- NCT05716230
- Acronym / sponsor ID
- NanjingCH0109
- Conditions
- Bowel Dysfunction
- Keywords
- anorectal malformation, Bowel function, risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nanjing Children's HospitalUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 29 Jan 2023 (actual)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study was designed to evaluate bowel function in preschool and early childhood in a large number of patients with anorectal Malformation and to identify the associated risk factors for bowel dysfunction.
Detailed description
Anorectal malformation (ARM) is a type of congenital malformation resulting from post-embryonic intestinal dysgenesis, occurring in about 1 in 5000 cases.Surgery is an effective means of treating ARM,which includes reconstruction of the anus and treatment of associated deformities. However, even with reconstruction of the anus, most children still have serious complications, such as constipation, fecal incontinence, urinary incontinence, and sexual dysfunction, in the mid-to-long postoperative period.A lot of studies have been designed to explore the trend toward normal bowel habits from preschool and early childhood age to adolescence or adult; however, no apparent improvement in bowel habits was completely confirmed. In contrast, many reports have shown that poor bowel function in preschool and early childhood may lead to social problems and depression in adolescence and adult.The reasons for bowel dysfunction of ARM in preschool and early childhood were complicated and undefined,including associated malformations, the type of ARM, and the development of the perianal sphincter,etc.The bowel function score (BFS) is currently used to assess mid- and long-term anal function in patients with ARM, and comprises seven major categories (e.g., self-perception, fecal control, stool collection, and social problems) with a total of 20 points, or less than 17 points, for the presence of anal weakness (11-17 points, for the general weakness, or less than 11 points, for the severe weakness) .Therefore,bowel function at preschool and early childhood should be evaluated in a large number of patients with ARM and the associated risk factors for bowel dysfunction should also be assessed. The present study was designed to evaluate bowel function in preschool and early childhood in a large number of patients with ARM and to identify the associated risk factors for bowel dysfunction using BFS.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ARM who were performed with surgery.The follow-up age was more than 4 years old.
Key inclusion criteria (1 listed)
- Anorectal malformation >4 years old
Key exclusion criteria (1 listed)
- Down syndrome patients <4 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bowel function score questionnaire surveyBowel function score(BFS, total 20 points) was approved by Rintala in 1995, and patients with a score ≥ 17 were considered to have normal bowel habits. 7 items were in BFS, including the ability to hold back defecation, feeling/reporting the urge to defecate, frequency of defecation, soiling, accidents, constipation. In December 2022, BFS questionnaire surveys were conducted on children with ARM who underwent surgical repair between January 2017 and December 2019 at Children's Hospital of Nanjing Medical University. | Other | – |
Primary outcome
bowel function score in partipants with ARM
Time frame: through study completion, an average of 6 year
approved by Rintala in 1995, and patients with a score ≥ 17 were considered to have normal bowel habits
1 secondary outcome
Sacral ratio in partipants with ARM
Time frame: through study completion, an average of 6 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 37935997Lu C, Pan S, Chen H, Tang W. Bowel function and features of bowel dysfunction in preschool children with anorectal malformation type rectoperineal and rectovestibular fistula. Eur J Pediatr. 2024 Feb;183(2):599-610. doi: 10.1007/s00431-023-05306-4. Epub 2023 Nov 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weibing Tang, Dr study director
Children's Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Dysfunction, run by Nanjing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Changgui Lu, Dr (13770848448, luchanggui1984@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bowel function score in partipants with ARM (time frame: through study completion, an average of 6 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05716230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.