Long-term Outcome in Patients With Anorectal Malformations

NCT02624232 | Unknown DMC

• 1 other identifier: S-20140017
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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:

• 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

Keywords

Anorectal malformation; Anorectal atresia; anorectal stenosis; Follow-Up Studies

Outcome Measures

Primary Outcomes (1)

• Correlation between anorectal pathoanatomy and gastrointestinal symptoms/quality of life

  Up to 6 years

Secondary Outcomes (1)

• Correlation between gastrointestinal symptoms and quality of life

  Up to 6 years

Study Arms (1)

Patients with anorectal malformations

Participants are identified through relevant diagnostic codes in ICD-10(Q 42) and ICD-9(75.120, 75.121) in 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:anorectal manometry, endoanal ultrasonography, pudendal nerve conduction velocity, colon transit time, Magnetic resonans(MR)-scan of the pelvis and uroflowmetry.

Eligibility Criteria

• Age: 10 Years - 31 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants are born with anorectal malformations and subjected to surgery at the Odense University Hospital during the period 1985 - 2004.

You may qualify if:

• Surgery for anorectal malformations

You may not qualify if:

• Severe mental disability

Sponsors & Collaborators

• Odense University Hospital: lead
• Aarhus University Hospital: collaborator
• University of Southern Denmark: collaborator

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Related Links

• webpage

MeSH Terms

Conditions

Anorectal Malformations

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Niels Qvist, Professor

  Research unit for Surgery

  STUDY DIRECTOR

Central Study Contacts

Thomas Bjørsum-Meyer, M.D.

CONTACT

27896089; thomas.bjoersum-meyer@rsyd.dk

Niels Qvist, Professor

CONTACT

65412236; famqvist@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.,ph.d-student

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: December 8, 2015
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2020
• Last Updated: December 8, 2015

Record last verified: 2015-12