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

NCT ID: NCT01323166

Last Updated: 2015-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-10-31

Brief Summary

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.

Detailed 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.

Conditions

Rectal Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Excision of the levator muscle

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

Excision of the levator muscle

Intervention Type: PROCEDURE

Cylindrical perineal excision including the levator muscle

Traditional perineal operation

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

Excision of the levator muscle

Intervention Type: PROCEDURE

Cylindrical perineal excision including the levator muscle

Interventions

Excision of the levator muscle

Cylindrical perineal excision including the levator muscle

Intervention Type: PROCEDURE

Other Intervention Names

Abdomino perineal resection; Extra levator excision; Perineal excision

Eligibility Criteria

Inclusion Criteria

• rectal cancer operated by abdominoperineal resection 2004-2009

Exclusion Criteria

• no informed consent

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swedish Cancer Foundation

OTHER

Sponsor Role: collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eva Angenete

M.D., Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva Angenete, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Surgery, Sahlgernska Univesity Hospital/Ostra

Locations

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, , Sweden

Countries

Sweden

References

Angenete E, Asplund D, Andersson J, Haglind E. Self reported experience of sexual function and quality after abdominoperineal excision in a prospective cohort. Int J Surg. 2014 Nov;12(11):1221-7. doi: 10.1016/j.ijsu.2014.10.003. Epub 2014 Oct 12.

Reference Type: DERIVED

PMID: 25311774 (View on PubMed)

Other Identifiers

QoL after APR at SU

Identifier Type: -

Identifier Source: org_study_id