Clinical Trial: Long-term Outcome in Patients With Anorectal Malformations
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Long-term Outcome in Patients Operated for Congenital Anorectal Malformations
Background Anorectal malformations(ARM) are rare and cover congenital defective development of rectum.
ARM include a range of congenital conditions and may in varying degrees involve the anorectum. A significant part have malformations in other organs mainly the urinary tract.
In the vast majority ARM are recognized at birth by lack of a normal anus. The primary approach is construction of a stoma and subsequent reconstruction. Bowel continuity is typical restored after 4-6 months.
Many patients experience abnormal bowel function later on and affected quality of life(QoL).
The primary objective is to assess the patient-related outcome 10-30 years after surgery for ARM and to see if it related to existing damage to anorectum and bowel function. The secondary objective is to identify problems with bowel function which may be treated medically or by surgery to improve bowel function and QoL. To obtain the necessary knowledge the study is divided in the following sub-projects:
- Assessment of bowel function and QoL through relevant questionnaires
- Examine sphincter anatomy and function through rectal ultrasound, magnetic resonans(MR)-scan of the pelvis and anal manometry. Bowel function is assessed through colonic transit time. Screening for urinary tract problems with uroflowmetry.
Methods Participants are identified through relevant diagnostic codes(Q 42) and patients which underwent surgery for ARM in the years 1985-2005 are included if informed consent is obtained.
Endpoints The primary endpoints are outcome 10-30 years after surgery for anorectal malformations and to see if it is related to existing altered anatomy, anorectal function and intestinal passage.
The secondary endpoints is to identify bowel function problems which can be treated by medicine or surgery to improve patients bowel function and quality of life.
To obtain the necessary knowledge the study will be divided in the following
- Evaluation of bowel function and quality of life with relevant questionnaire.
- Examine anorectal anatomy and function with anal ultrasound, Magnetic resonans(MR)-scan of the small pelvis and anal manometry. Overall bowel function is examined with colonic transit time. Screening for urinary problems with urodynamic testing.
Background Anorectal malformations(ARM) cover a wide spectrum of congenital disorders seen in both sexes and may also involve the urinary tract and genitals. It occurs in 1/2500 of newborns with a slight predominance in boys and 2/3 have accompanying anomalies. ARM form as an abnormal development of the hindgut which later forms the descending colon, rectum, anus, bladder and urethra. This explains frequent recurrence of accompanying malformations in the urinary tract.
The reason for the development of ARM is unknown. The etiology is probably multifactorial including both heredity and environment. A chromosomal anomaly is found among 5% of patients with ARM and Trisomy 21 being most common. Possible risk factors is maternal fever in the fir
Sponsor: Odense University Hospital
Current Primary Outcome: Correlation between anorectal pathoanatomy and gastrointestinal symptoms/quality of life [ Time Frame: Up to 6 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Correlation between gastrointestinal symptoms and quality of life [ Time Frame: Up to 6 years ]
Original Secondary Outcome: Same as current
Information By: Odense University Hospital
Date Received: November 17, 2015
Date Started: January 2016
Date Completion: October 2020
Last Updated: December 4, 2015
Last Verified: December 2015