Bowel Function & Associated Risk Factors for Bowel Dysfunciton in Patients

Status Recruiting

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05716230
Study type	Observational
Source	Nanjing Children's Hospital
Contact	Changgui Lu, Dr
Phone	13770848448
Email	luchanggui1984@163.com
Status	Recruiting
Phase
Start date	November 20, 2022
Completion date	February 28, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04205058` - Coffee After Pancreatic Surgery	N/A
Recruiting	`NCT05380856` - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction	N/A
Completed	`NCT00135577` - Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects	Phase 2
Completed	`NCT03028636` - LIBERATE - PRO: Eclipse™ System Registry
Active, not recruiting	`NCT05880446` - PROstate CAncer Radiotherapy - Bowel Quality of Life (PROCAR-BQ)	N/A
Active, not recruiting	`NCT06311110` - Impaired Toilet Training, LUTS and Bowel Dysfunction in Children With DCD
Not yet recruiting	`NCT04507945` - Stablishment of Prevention and Treatment System for Intestinal Dysfunction	Phase 1/Phase 2
Completed	`NCT00101998` - Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication	Phase 2
Completed	`NCT05644912` - Exploratory Investigation on a Novel Catheter	N/A
Recruiting	`NCT04319991` - The Clinical Evaluation of Probiotics Product in Patients With Various Functional Bowel Disorders and Helicobacter Pylori Infection	N/A
Completed	`NCT03885999` - Studies in Patients With Low Anterior Resection Syndrome (LARS)	N/A
Active, not recruiting	`NCT04546672` - Sugammadex To IMprove Bowel Function	Phase 4
Not yet recruiting	`NCT06252714` - Impact of Defecation Posture on Ease of Bowel Movements in Patients With a Rectocele	N/A
Recruiting	`NCT04914975` - The Effect of NMES on Bowel Management in People With Chronic SCI	N/A
Active, not recruiting	`NCT04490642` - Linguistic Validation of the Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ) for 5-12 Years Old in Korean
Completed	`NCT04299867` - Perioperative Tissue Penetration of Antimicrobials in Infants
Recruiting	`NCT06288464` - Enteral Feeding of Fibre to Improve Microbiota	N/A
Completed	`NCT05351138` - Comparison of Transcutaneous Electrical Nerve Stimulation and Manual Therapy in Children With Cerebral Palsy	N/A
Completed	`NCT03841513` - Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence	N/A
Not yet recruiting	`NCT03009747` - A Prospective Multi-Center Research on Bowel Dysfunction After Sphincter Preservative Surgery	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Bowel Function and Associated Risk Factors for Bowel Dysfunciton in Patients With Anorectal Malformation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms