Rectal CancerAPRNCT01323166
Quality of Life After Abdominoperineal Resection for Rectal Cancer, Comparing Two Surgical Techniques
An observational study of Rectal Cancer, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Excision of the levator muscle
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2011to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: colorectal section of one university hospital
Who may be able to join
- rectal cancer operated by abdominoperineal resection 2004-2009
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, SE 416 85
About this study
Official title: Retrospective Study of APR Results Regarding Patients' Self Reported Quality of Life
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.
Read the 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
- Being tested
- Excision of the levator muscle
- Keywords
- rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excision of the levator muscleProcedure or surgery
Also called Abdomino perineal resection, Extra levator excision, Perineal excision
Cylindrical perineal excision including the levator muscle
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Excision of the levator muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2-7 years after operation
Secondary outcomes (2)
Impact of rectal cancer surgery on household finances in a long-term perspective
Part of the questionnaire deals with the patients'/spouses' career and economic situation after the operation.
Measured: 2-7 years after operation
Impact of rectal cancer surgery and the level of intrusive thoughts
Part of the questionnaire analyses occurrence and effects of intsrusice thoughts
Measured: 2-7 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Cancer Foundation
- Responsible party
- Principal investigator, Eva Angenete, Sahlgrenska University Hospital
- Investigators
- Eva Angenete, MD,PhD, Principal investigator, Dept. of Surgery, Sahlgernska Univesity Hospital/Ostra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323166
- Sponsor's protocol ID
- QoL after APR at SU
- Acronym
- APR
- Status last verified
- Sep 2015
- First submitted
- 24 Mar 2011
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25311774
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of APR Results Regarding Patients' Self Reported Quality of Life
- ClinicalTrials.gov ID
- NCT01323166
- Acronym / sponsor ID
- APR / QoL after APR at SU
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Swedish Cancer Foundation
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Excision of the levator muscle | – | Procedure: Excision of the levator muscleThe 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 |
| Traditional perineal operation | – | Procedure: Excision of the levator muscleThe 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- colorectal section of one university hospital
Key inclusion criteria (1 listed)
- rectal cancer operated by abdominoperineal resection 2004-2009
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excision of the levator muscleAlso: Abdomino perineal resection, Extra levator excision, Perineal excisionCylindrical perineal excision including the levator muscle | Procedure or surgery | Excision of the levator muscle, Traditional perineal operation |
Primary outcome
Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure
Time frame: 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
2 secondary outcomes
Impact of rectal cancer surgery on household finances in a long-term perspective
Time frame: 2-7 years after operation
Impact of rectal cancer surgery and the level of intrusive thoughts
Time frame: 2-7 years after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
- Derived from this study: PubMed 25311774Angenete 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.
- Related infoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Angenete, MD,PhD principal investigator
Dept. of Surgery, Sahlgernska Univesity Hospital/Ostra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure (time frame: 2-7 years after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01323166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015.