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

Rectal Cancer Clinical Trial

— APER  

Official title:

A Registry Based Study of Clinical Results and of Health and Wellbeing in Patients After Abdominoperineal Resection for Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296984
• Other study ID #: SSORG APER
• Status: Completed
• Phase: N/A
• First received: February 15, 2011
• Last updated: November 17, 2014
• Start date: February 2011
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

The aim of the project is to evaluate the oncological and functional outcome of the more extensive perineal dissection - i.e the extra levator resection - in abdominoperineal resections in patients with rectal cancer.

Hypothesis: Extra levator perineal resection reduces local recurrence three year postoperatively compared to traditional abdominoperineal resection and improves QoL 2-4 years postoperatively.

Description:

Low rectal cancer treated surgically by abdominoperineal resection (APR) has worse outcome than other rectal cancers operated with low anterior resection. In order to improve the outcome in the APR group a more extensive surgical procedure - the extra levator APR - has been suggested. This study aims to investigate both the oncological and the functional outcome of this method as compared to the traditional APR.

Method: All Swedish patients undergoing abdominoperineal resection for rectal cancer 2007-2009 will be analysed regarding operative technique (traditional or extra levator resection). Data on all patients regarding pre op TNM classification, pathological report and local recurrence will be collected from the Swedish Rectal Cancer registry. A validated QoL form will be sent to each patient to further investigate the functional outcome, health economy and Quality of Life 2-4 years postoperatively.

Data will be analysed regarding 3 year recurrence rate (primary endpoint) as well as functional result and QoL (secondary endpoints) in the two different groups - i.e traditional and extra levator APR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1319
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Rectal cancer operated with APR 2007-2009

Exclusion Criteria:

• No informed consent

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
Sweden	SSORG, Sahlgrenska Universitetssjukhuset, Område 2	Gothenburg	Västra Götalandsregionen

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Swedish Cancer Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year local recurrence	Local recurrence of rectal cancer 3 years after APR	3 years postoperatively	No
Secondary	Postoperative complications	postoperative morbidity: wound infection, deep infections, other infections, wound necrosis, pain, pneumonia, thrombosis	30 days	No
Secondary	Reoperation, readmittance and mortality	Re-operation/s, length of hospital stay/s, re-admittance/s, mortality all within 12 months of primary surgery	12 months	No
Secondary	Late morbidity	Late morbidity and functional disorders: prolonged wound healing, late infections, limping, pain, sitting problems, urinary incontinence, erectile dysfunction, stoma related dysfunction	24-48 months postoperatively	No
Secondary	Quality of Life	Patient experienced health and QoL 24-48 months postoperatively	24-48 months postoperatively	No
Secondary	Health economy	Health economy analysis of resource consumption	24-48 months postoperatively	No
Secondary	Stoma function	Assessment of stoma function related both to construction and surgical technique and patient position	24-36 months postop	No

External Links

•   Website of SSORG