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Long-term Outcome in Patients With Anorectal Malformations (LOPAM)

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ClinicalTrials.gov Identifier: NCT02624232
Recruitment Status : Not yet recruiting
First Posted : December 8, 2015
Last Update Posted : December 8, 2015
Sponsor:
Collaborators:
Aarhus University Hospital
University of Southern Denmark
Information provided by (Responsible Party):
Thomas Bjørsum-Meyer, Odense University Hospital

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:

  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.


Condition or disease
Anorectal Malformation

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Outcome in Patients Operated for Congenital Anorectal Malformations
Study Start Date : January 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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.




Primary Outcome Measures :
  1. Correlation between anorectal pathoanatomy and gastrointestinal symptoms/quality of life [ Time Frame: Up to 6 years ]

Secondary Outcome Measures :
  1. Correlation between gastrointestinal symptoms and quality of life [ Time Frame: Up to 6 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 31 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Surgery for anorectal malformations

Exclusion Criteria:

  • Severe mental disability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624232


Contacts
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Contact: Thomas Bjørsum-Meyer, M.D. 27896089 thomas.bjoersum-meyer@rsyd.dk
Contact: Niels Qvist, Professor 65412236 famqvist@dadlnet.dk

Sponsors and Collaborators
Odense University Hospital
Aarhus University Hospital
University of Southern Denmark
Investigators
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Study Director: Niels Qvist, Professor Research unit for Surgery

Additional Information:
Publications:
Wittrup-Jensen KU, Lauridsen JT, Gudex C et al. Estimating Danish EQ-5D tariffs using TTO and VAS. In: Norinder A, Pedersen K, Roos P, editors. Proceedings of the 18th Plenary Meeting of the EuroQol Group. IHE, The Swedish Institute for Health Economics 2002; 257-292.

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Responsible Party: Thomas Bjørsum-Meyer, M.D.,ph.d-student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02624232     History of Changes
Other Study ID Numbers: S-20140017
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015
Keywords provided by Thomas Bjørsum-Meyer, Odense University Hospital:
Anorectal malformation
Anorectal atresia
anorectal stenosis
Follow-Up Studies
Additional relevant MeSH terms:
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Anorectal Malformations
Congenital Abnormalities
Digestive System Abnormalities
Digestive System Diseases