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

Study Overview
=================
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.

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

Conditions
-----------------
Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rectal cancer operated with APR 2007-2009 Exclusion Criteria: No informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Extralevator APR<br>The perineal part of the APR is done with the intent to create a cylindrically shaped specimen thus removing part of or the entire levator muscle with the specimen. | |
| Traditional APR<br>The perineal part of the APR is performed with the intent to remove the tumour with CRM free of tumour and the levator left in place. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year local recurrence | Local recurrence of rectal cancer 3 years after APR | 3 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | postoperative morbidity: wound infection, deep infections, other infections, wound necrosis, pain, pneumonia, thrombosis | 30 days | 
| 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 | 
| 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 | 
| Quality of Life | Patient experienced health and QoL 24-48 months postoperatively | 24-48 months postoperatively | 
| Health economy | Health economy analysis of resource consumption | 24-48 months postoperatively | 
| Stoma function | Assessment of stoma function related both to construction and surgical technique and patient position | 24-36 months postop | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rectal cancer, APR