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

Completed

• Conditions: Rectal Cancer

• Registration Number: NCT01296984
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-02-15
• Study First Posted: 2011-02-16
• Primary Completion: 2014-03
• Study Completion: 2014-06
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1319

Inclusion Criteria

• Rectal cancer operated with APR 2007-2009

Exclusion Criteria

• No informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year local recurrence	3 years postoperatively	Local recurrence of rectal cancer 3 years after APR

Secondary Outcome Measures

Name	Time	Method
Reoperation, readmittance and mortality	12 months	Re-operation/s, length of hospital stay/s, re-admittance/s, mortality all within 12 months of primary surgery
Stoma function	24-36 months postop	Assessment of stoma function related both to construction and surgical technique and patient position
Late morbidity	24-48 months postoperatively	Late morbidity and functional disorders: prolonged wound healing, late infections, limping, pain, sitting problems, urinary incontinence, erectile dysfunction, stoma related dysfunction
Quality of Life	24-48 months postoperatively	Patient experienced health and QoL 24-48 months postoperatively
Postoperative complications	30 days	postoperative morbidity: wound infection, deep infections, other infections, wound necrosis, pain, pneumonia, thrombosis
Health economy	24-48 months postoperatively	Health economy analysis of resource consumption

Trial Locations

Locations (1)

SSORG, Sahlgrenska Universitetssjukhuset, Område 2; 🇸🇪 Gothenburg, Västra Götalandsregionen, Sweden