Oncological and Functional Result of AbdominoPerineal Extra Levator Resection for Distal Rectal Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01296984
• Date of registration: 15/02/2011
• Prospective Registration: No
• Primary sponsor: Sahlgrenska University Hospital, Sweden
• Public title: Oncological and Functional Result of AbdominoPerineal Extra Levator Resection for Distal Rectal Cancer APER
• Scientific title: A Registry Based Study of Clinical Results and of Health and Wellbeing in Patients After Abdominoperineal Resection for Rectal Cancer
• Date of first enrolment: February 2011
• Target sample size: 1319
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01296984
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Retrospective
• Phase: N/A

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

- Rectal cancer operated with APR 2007-2009

Exclusion Criteria:

- No informed consent



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rectal Cancer

Primary Outcome(s)

3-year local recurrence [Time Frame: 3 years postoperatively]

Secondary Outcome(s)

Quality of Life [Time Frame: 24-48 months postoperatively]

Postoperative complications [Time Frame: 30 days]

Reoperation, readmittance and mortality [Time Frame: 12 months]

Stoma function [Time Frame: 24-36 months postop]

Late morbidity [Time Frame: 24-48 months postoperatively]

Health economy [Time Frame: 24-48 months postoperatively]

Secondary ID(s)

SSORG APER

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Swedish Cancer Foundation