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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Swedish Cancer Foundation
Information provided by (Responsible Party):
Eva Angenete, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01296984
First received: February 15, 2011
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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.


Condition
Rectal Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Registry Based Study of Clinical Results and of Health and Wellbeing in Patients After Abdominoperineal Resection for Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • 3-year local recurrence [ Time Frame: 3 years postoperatively ] [ Designated as safety issue: No ]
    Local recurrence of rectal cancer 3 years after APR


Secondary Outcome Measures:
  • Postoperative complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    postoperative morbidity: wound infection, deep infections, other infections, wound necrosis, pain, pneumonia, thrombosis

  • Reoperation, readmittance and mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Re-operation/s, length of hospital stay/s, re-admittance/s, mortality all within 12 months of primary surgery

  • Late morbidity [ Time Frame: 24-48 months postoperatively ] [ Designated as safety issue: No ]
    Late morbidity and functional disorders: prolonged wound healing, late infections, limping, pain, sitting problems, urinary incontinence, erectile dysfunction, stoma related dysfunction

  • Quality of Life [ Time Frame: 24-48 months postoperatively ] [ Designated as safety issue: No ]
    Patient experienced health and QoL 24-48 months postoperatively

  • Health economy [ Time Frame: 24-48 months postoperatively ] [ Designated as safety issue: No ]
    Health economy analysis of resource consumption

  • Stoma function [ Time Frame: 24-36 months postop ] [ Designated as safety issue: No ]
    Assessment of stoma function related both to construction and surgical technique and patient position


Estimated Enrollment: 800
Study Start Date: February 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Extralevator APR
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
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All swedish patients registerd in the swedish rectalcancer registry undergoing APR 2007-2009

Criteria

Inclusion Criteria:

  • Rectal cancer operated with APR 2007-2009

Exclusion Criteria:

  • No informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296984

Locations
Sweden
SSORG, Sahlgrenska Universitetssjukhuset, Område 2
Gothenburg, Västra Götalandsregionen, Sweden, 416 85
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Swedish Cancer Foundation
  More Information

Additional Information:
No publications provided by Sahlgrenska University Hospital, Sweden

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eva Angenete, M.D., Ph.D., Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01296984     History of Changes
Other Study ID Numbers: SSORG APER
Study First Received: February 15, 2011
Last Updated: December 12, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Sahlgrenska University Hospital, Sweden:
Rectal cancer
APR

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014