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

Sahlgrenska University Hospital

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: Excision of the levator muscle

Study type: Observational

Funder types: Other

Identifiers

NCT01323166

QoL after APR at SU

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• rectal cancer operated by abdominoperineal resection 2004-2009

Exclusion criteria

• no informed consent

Trial design

75 participants in 2 patient groups

Excision of the levator muscle

Description:

The abdominal part of the operation is performed as an TME and the perineal part of the operation is performed with the intent to get a cylindrical specimen thus removing part of or the entire levator muscle with the specimen

Treatment:

Procedure: Excision of the levator muscle

Traditional perineal operation

Description:

The abdominal part of the operation performed as a TME. The perineal operation performed with the intent of removing the tumour with CRM free of tumour and the levator left in place

Treatment:

Procedure: Excision of the levator muscle