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Completed

NCT Number: NCT01323166

Quality of Life After Abdominoperineal Resection for Rectal Cancer, Comparing Two Surgical Techniques

The purpose of the study is to compare self-reported health related quality of life after two different operating techniques for low rectal cancer operated by rectal amputation, using a specific and detailed questionnaire. The population has been operated over a 6 year period in one university hospital.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

About this study

Low rectal cancer treated by abdominoperineal resection (APR, rectal amputation)has worse prognosis than other rectal cancers, both regarding local recurrence and cancer specific survival. With a view to improve local recurrence rates a more extensive perineal operation (excision of the levator muscle) has been suggested. In our university hospital thie technique was introduced for all surgeons January 2007. A population of all patients operated from 1 January 2007 to 31 December 2009 was compared to all patients operated from 1 January 2004 to 31 December 2006 using the traditional, less extensive method, in all a six year period and 158 patients.

A specific questionnaire was developed after in depth interviews, and was face-validated by patients who had undergone an APR. This questionnaire will be sent out to all patients in our population who are still alive.

The patients will be contacted first by a letter of invitation, later called by telephone to be given more information and asked for permission to send the questionnaire.

The send out of invitation letters will start March 2011.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • rectal cancer operated by abdominoperineal resection 2004-2009

Exclusion criteria

  • no informed consent

Treatment and study plan

Excision of the levator muscle

Procedure

Cylindrical perineal excision including the levator muscle

Other names: Abdomino perineal resection, Extra levator excision, Perineal excision

Primary outcomes

  1. Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure

    Time frame: 2-7 years after operation

    A detailed questionnaire with 250 questions, where emphasis is on physical satisfaction and emotional status as well as bowel function, sexual function and stoma function 2-7 years after rectal amputation

Secondary outcomes

  1. Impact of rectal cancer surgery on household finances in a long-term perspective

    Time frame: 2-7 years after operation

    Part of the questionnaire deals with the patients'/spouses' career and economic situation after the operation.

  2. Impact of rectal cancer surgery and the level of intrusive thoughts

    Time frame: 2-7 years after operation

    Part of the questionnaire analyses occurrence and effects of intsrusice thoughts

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Swedish Cancer Foundation

Registry information

Official study title

Retrospective Study of APR Results Regarding Patients' Self Reported Quality of Life

Acronym: APR

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 25, 2011
Registry last updated
Sep 4, 2015

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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