Longterm Outcomes of Individuals With Anorectal Malformations

NCT04901819 | Completed

• 2 other identifiers: FOR 4-1500/2021K 2021-4578
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a cross-sectional observational study with the aim to assess longterm outcomes in a large cohort of individuals with anorectal malformations. Patients managed for anorectal malformations at Karolinska University Hospital, Stockholm, Sweden, Stockholm 1994-2017 will be reviewed and they will be invited to respond to validated questionnaires evaluating bowel function (\>4 years of age), urinary tract function (\>4 years of age), sexual function (\>18 years of age) and quality of life (\>8 years of age). Data will be analyzed with descriptive and comparative statistics.

Conditions

Anorectal Malformations

Outcome Measures

Primary Outcomes (3)

• Bowel function score

  Bowel function score, BFS, \>4 years of age (Rintala et al. J Pediatr Surg 1995;30:491-4)

  3 years

• Urinary tract function

  Urinary tract function evaluated with a modification of Danish Prostatic Symptom Score, \>4 years of age (Kyrklund et al Dis Colon Rectum 2012;55:671-6)

  3 years

• Sexual function

  Sexual function evaluated with Profile of Female Sexual Function in females \>18 years of age and with IIEF in males \>18 years of age

  3 years

Eligibility Criteria

• Age: 4 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individual who have undergone surgical management for anorectal malformations at Karolinska University Hospital, Stockholm, Sweden from 1994 to 2017.

You may qualify if:

• Individual who has undergone surgical management for anorectal malformation at Karolinska University Hospital 1994 to 2017.

You may not qualify if:

• Individual not providing informed consent.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (4)

• Svenningsson A, Gunnarsdottir A, Wester T. Maternal risk factors and perinatal characteristics of anorectal malformations. J Pediatr Surg. 2018 Nov;53(11):2183-2188. doi: 10.1016/j.jpedsurg.2018.04.021. Epub 2018 Apr 17.

  PMID: 29907315 BACKGROUND

• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.

  PMID: 18064739 BACKGROUND

• Rintala RJ, Lindahl H. Is normal bowel function possible after repair of intermediate and high anorectal malformations? J Pediatr Surg. 1995 Mar;30(3):491-4. doi: 10.1016/0022-3468(95)90064-0.

  PMID: 7760250 BACKGROUND

• Kyrklund K, Koivusalo A, Rintala RJ, Pakarinen MP. Evaluation of bowel function and fecal continence in 594 Finnish individuals aged 4 to 26 years. Dis Colon Rectum. 2012 Jun;55(6):671-6. doi: 10.1097/DCR.0b013e31824c77e4.

  PMID: 22595847 BACKGROUND

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

• Tomas Wester, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 26, 2021
• Study Start: January 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)