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Completed

NCT Number: NCT01296984

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

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SSORG, Sahlgrenska Universitetssjukhuset, Område 2

Gothenburg, Västra Götalandsregionen, 416 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Rectal cancer operated with APR 2007-2009

Exclusion criteria

  • No informed consent

Treatment and study plan

Primary outcomes

  1. 3-year local recurrence

    Time frame: 3 years postoperatively

    Local recurrence of rectal cancer 3 years after APR

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Swedish Cancer Foundation

Registry information

Official study title

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

Acronym: APER

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 16, 2011
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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