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

NCT01323166 | Completed

• 1 other identifier: QoL after APR at SU
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

rectal cancer

Outcome Measures

Primary Outcomes (1)

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

  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

  2-7 years after operation

Secondary Outcomes (2)

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

  2-7 years after operation

• Impact of rectal cancer surgery and the level of intrusive thoughts

  2-7 years after operation

Study Arms (2)

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

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

Interventions

Excision of the levator muscle PROCEDURE

Cylindrical perineal excision including the levator muscle

Also known as: Abdomino perineal resection, Extra levator excision, Perineal excision

Excision of the levator muscle; Traditional perineal operation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

colorectal section of one university hospital

You may qualify if:

• rectal cancer operated by abdominoperineal resection 2004-2009

You may not qualify if:

• no informed consent

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Swedish Cancer Foundation: collaborator

Study Sites (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

Location

Related Publications (1)

• 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.

  PMID: 25311774 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Proctectomy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Eva Angenete, MD,PhD

  Dept. of Surgery, Sahlgernska Univesity Hospital/Ostra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 25, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

SE (1)