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
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.
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
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|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|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|
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.
- Correlation between anorectal pathoanatomy and gastrointestinal symptoms/quality of life [ Time Frame: Up to 6 years ]
- Correlation between gastrointestinal symptoms and quality of life [ Time Frame: Up to 6 years ]
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
|Contact: Thomas Bjørsum-Meyer, M.D.||firstname.lastname@example.org|
|Contact: Niels Qvist, Professoremail@example.com|
|Study Director:||Niels Qvist, Professor||Research unit for Surgery|