COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01296984
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : November 19, 2014
Swedish Cancer Foundation
Information provided by (Responsible Party):
Eva Angenete, 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.

Condition or disease
Rectal Cancer

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1319 participants
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
Study Start Date : February 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : June 2014

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.

Primary Outcome Measures :
  1. 3-year local recurrence [ Time Frame: 3 years postoperatively ]
    Local recurrence of rectal cancer 3 years after APR

Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 days ]
    postoperative morbidity: wound infection, deep infections, other infections, wound necrosis, pain, pneumonia, thrombosis

  2. Reoperation, readmittance and mortality [ Time Frame: 12 months ]
    Re-operation/s, length of hospital stay/s, re-admittance/s, mortality all within 12 months of primary surgery

  3. Late morbidity [ Time Frame: 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

  4. Quality of Life [ Time Frame: 24-48 months postoperatively ]
    Patient experienced health and QoL 24-48 months postoperatively

  5. Health economy [ Time Frame: 24-48 months postoperatively ]
    Health economy analysis of resource consumption

  6. Stoma function [ Time Frame: 24-36 months postop ]
    Assessment of stoma function related both to construction and surgical technique and patient position

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All swedish patients registerd in the swedish rectalcancer registry undergoing APR 2007-2009

Inclusion Criteria:

  • Rectal cancer operated with APR 2007-2009

Exclusion Criteria:

  • No informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01296984

Layout table for location information
SSORG, Sahlgrenska Universitetssjukhuset, Område 2
Gothenburg, Västra Götalandsregionen, Sweden, 416 85
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Swedish Cancer Foundation
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eva Angenete, M.D., Ph.D., Sahlgrenska University Hospital, Sweden Identifier: NCT01296984    
Other Study ID Numbers: SSORG APER
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014
Keywords provided by Eva Angenete, Sahlgrenska University Hospital, Sweden:
Rectal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases