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

This study has been completed.
Sponsor:
Collaborator:
Swedish Cancer Foundation
Information provided by (Responsible Party):
Eva Angenete, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01323166
First received: March 24, 2011
Last updated: November 14, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Rectal Cancer
Procedure: Excision of the levator muscle

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Retrospective Study of APR Results Regarding Patients' Self Reported Quality of Life

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure [ Time Frame: 2-7 years after operation ] [ Designated as safety issue: Yes ]
    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:
  • Impact of rectal cancer surgery on household finances in a long-term perspective [ Time Frame: 2-7 years after operation ] [ Designated as safety issue: No ]
    Part of the questionnaire deals with the patients'/spouses' career and economic situation after the operation.

  • Impact of rectal cancer surgery and the level of intrusive thoughts [ Time Frame: 2-7 years after operation ] [ Designated as safety issue: Yes ]
    Part of the questionnaire analyses occurrence and effects of intsrusice thoughts


Enrollment: 75
Study Start Date: March 2011
Study Completion Date: October 2011
Groups/Cohorts Assigned Interventions
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
Procedure: Excision of the levator muscle
Cylindrical perineal excision including the levator muscle
Other Names:
  • Abdomino perineal resection
  • Extra levator excision
  • Perineal excision
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
Procedure: Excision of the levator muscle
Cylindrical perineal excision including the levator muscle
Other Names:
  • Abdomino perineal resection
  • Extra levator excision
  • Perineal excision

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

colorectal section of one university hospital

Criteria

Inclusion Criteria:

  • rectal cancer operated by abdominoperineal resection 2004-2009

Exclusion Criteria:

  • no informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323166

Locations
Sweden
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, Sweden, SE 416 85
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Swedish Cancer Foundation
Investigators
Principal Investigator: Eva Angenete, MD,PhD Dept. of Surgery, Sahlgernska Univesity Hospital/Ostra
  More Information

Additional Information:
No publications provided

Responsible Party: Eva Angenete, M.D., Ph.D., Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01323166     History of Changes
Other Study ID Numbers: QoL after APR at SU
Study First Received: March 24, 2011
Last Updated: November 14, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Sahlgrenska University Hospital, Sweden:
rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 20, 2014