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

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: Excision of the levator muscle

• Registration Number: NCT01323166
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• rectal cancer operated by abdominoperineal resection 2004-2009

Exclusion Criteria

• no informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Traditional perineal operation	Excision of the levator muscle	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	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

Primary Outcome Measures

Name	Time	Method
Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure	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 Outcome Measures

Name	Time	Method
Impact of rectal cancer surgery and the level of intrusive thoughts	2-7 years after operation	Part of the questionnaire analyses occurrence and effects of intsrusice thoughts
Impact of rectal cancer surgery on household finances in a long-term perspective	2-7 years after operation	Part of the questionnaire deals with the patients'/spouses' career and economic situation after the operation.

Trial Locations

Locations (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra; 🇸🇪 Gothenburg, Sweden