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Long-term Outcome in Patients With Anorectal Malformations

NCT02624232 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2015-12-08

No results posted yet for this study

Summary

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).

Aim

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:

1. Assessment of bowel function and QoL through relevant questionnaires
2. 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.

Relevant questionnaires regarding symptoms and QoL are completed before the following examinations:

* Anal manometry
* Anal ultrasound
* Pudenda conduction velocity
* Colonic transit time
* Magnetic resonans(MR)-scan of lower abdomen and pelvis
* Uroflowmetry

Bowel function and QoL is assessed in both children and adults with relevant validated questionnaires.

Perspective No danish studies and only a few foreign investigate the relationship between anatomy/physiology and quality of life after surgery for anorectal malformations.

The investigators believe the study and included comprehensive examinations will clarify the causes of functional problems after surgery for anorectal malformations. Results of questionnaires regarding symptoms, disease-specific-and general quality of life offer a unique opportunity for targeted treatment to improve symptoms and QoL in patients with ARM.

Conditions

  • Anorectal Malformation

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • University of Southern Denmark

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Niels Qvist, Professor · Research unit for Surgery

Eligibility

Min Age
10 Years
Max Age
31 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-10-31
Completion
2020-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02624232 on ClinicalTrials.gov