Breast DiseasesTRAMNCT01438268
TRAM Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes
An observational study of Breast Diseases, run by Women's College Hospital at 1 site in Canada.
Trial summary
Specific Aim: To assess the quality of recovery of patients following early discharge (18 hrs) after pedicled TRAM flap breast reconstruction. Quality of recovery will be assessed using a 27-item validated questionnaire, QoR-27 at discharge, and on Post Operative Days (POD) 2, 4 and 7. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Diseases
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Jan 2014
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Reconstructive breast cancer patients
Who may be able to join
- Women undergoing any type of TRAM flap
- Age<75 yrs
- Non-smoker
Who cannot join
- History of chronic pain or psychiatric disturbance
- History of chronic use of opioid medications
- Allergy to local anesthesia or opioid medication
- Inability to communicate in English
- BMI>35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expedited Discharge of Patients Undergoing Pedicled TRAM Flap Breast Reconstruction Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes
Specific Aim: To assess the quality of recovery of patients following early discharge (18 hrs) after pedicled TRAM flap breast reconstruction. Quality of recovery will be assessed using a 27-item validated questionnaire, QoR-27 at discharge, and on Post Operative Days (POD) 2, 4 and 7. In addition a 100 mm Visual Analog Score (VAS) for Pain will be completed on discharge from the recovery room, discharge from hospital and on POD 2, 4 and 7.
Clinical Relevance: Postoperative recovery is a complex process related to various outcomes such as physiological endpoints, incidence of adverse events and change in psychological status. Previous studies of recovery after surgery and anesthesia have focused primarily on the physiological endpoints and the incidence of adverse events. Much of the work has occurred in specialties dealing with chronic disease states such as cancer, rheumatology and musculoskeletal disorders. There is clearly a need to focus on recovery outcome measures in the ambulatory population for postoperative recovery. Here the investigators propose to measure postoperative recovery outcomes within the first week following a TRAM flap reconstructive procedure using a validated postoperative quality of recovery instrument (QoR-27) and a 100 mm VAS for pain.
Read the detailed description
Women's College Hospital is the first and only independent ambulatory care hospital in Ontario, and the only hospital in Ontario with a primary focus on women's health. Patients undergoing breast reconstruction following breast cancer at our institution are now undergoing expedited discharge at 18 hrs postoperatively. To facilitate next day discharge, a multidisciplinary group was formed to determine the best evidence for perioperative care to ensure patient safety and excellent postoperative recovery. Minimizing length of stay has obvious cost savings for hospitals, but for patients the advantages include minimizing exposure to hospital-acquired infections and an earlier return to their more familiar home environment. The need to balance the advantage of early discharge to patient complications, however, must be addressed. As other hospitals across the country face the same length of stay constraints as has been our experience, this study will provide important data on the quality of recovery of patients undergoing early discharge following breast reconstructive surgery.
- Conditions
- Breast Diseases
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Reconstructive breast cancer patients | Patients having unilateral, bilateral immediate or delayed TRAM flaps who are discharged 18 hours postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27
The patient will be met with by the study coordinator, just before discharge to administer the Quality of Recovery Questionnaire (QoR27)
Measured: On average between 18 and 24 hours postoperatively
The primary outcome measure is the quality of recovery post operatively, as assessed by the QoR27
The patient will be contacted by the study coordinator, 2 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)
Measured: on average between 48-72 hours postoperatively
The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27
The patient will be contacted by the study coordinator, 4 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)
Measured: On average 72-96 hours post operatively
The primary outcome measure is the quality of recovery post operatively as assessed by the QoR27
The patient will be contacted by the study coordinator, 7 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)
Measured: On average 7-8 days postoperatively
Secondary outcomes (1)
The secondary outcome measure is the quality of recovery as assessed by the VAS pain score
These scores will be compared
Measured: This outcome will be done at the exact same time as the measurements of Quality of Recovery listed above
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2013
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor
- Investigators
- John L Semple, MD, MSc, FRCSC, FACS, Principal investigator, Women's College HospitalPamela J Morgan, MD, CCFP, FRCPC, Study director, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438268
- Sponsor's protocol ID
- 2010-0050-E
- Acronym
- TRAM
- Status last verified
- Nov 2013
- First submitted
- 21 Jun 2011
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expedited Discharge of Patients Undergoing Pedicled TRAM Flap Breast Reconstruction Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes
- ClinicalTrials.gov ID
- NCT01438268
- Acronym / sponsor ID
- TRAM / 2010-0050-E
- Conditions
- Breast Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, Ontario Ministry of Health and Long Term Care
- Study start
- Jul 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jan 2014 (estimated)
- First posted
- 22 Sep 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.
Specific Aim: To assess the quality of recovery of patients following early discharge (18 hrs) after pedicled TRAM flap breast reconstruction. Quality of recovery will be assessed using a 27-item validated questionnaire, QoR-27 at discharge, and on Post Operative Days (POD) 2, 4 and 7. In addition a 100 mm Visual Analog Score (VAS) for Pain will be completed on discharge from the recovery room, discharge from hospital and on POD 2, 4 and 7.
Clinical Relevance: Postoperative recovery is a complex process related to various outcomes such as physiological endpoints, incidence of adverse events and change in psychological status. Previous studies of recovery after surgery and anesthesia have focused primarily on the physiological endpoints and the incidence of adverse events. Much of the work has occurred in specialties dealing with chronic disease states such as cancer, rheumatology and musculoskeletal disorders. There is clearly a need to focus on recovery outcome measures in the ambulatory population for postoperative recovery. Here the investigators propose to measure postoperative recovery outcomes within the first week following a TRAM flap reconstructive procedure using a validated postoperative quality of recovery instrument (QoR-27) and a 100 mm VAS for pain.
Detailed description
Women's College Hospital is the first and only independent ambulatory care hospital in Ontario, and the only hospital in Ontario with a primary focus on women's health. Patients undergoing breast reconstruction following breast cancer at our institution are now undergoing expedited discharge at 18 hrs postoperatively. To facilitate next day discharge, a multidisciplinary group was formed to determine the best evidence for perioperative care to ensure patient safety and excellent postoperative recovery. Minimizing length of stay has obvious cost savings for hospitals, but for patients the advantages include minimizing exposure to hospital-acquired infections and an earlier return to their more familiar home environment. The need to balance the advantage of early discharge to patient complications, however, must be addressed. As other hospitals across the country face the same length of stay constraints as has been our experience, this study will provide important data on the quality of recovery of patients undergoing early discharge following breast reconstructive surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reconstructive breast cancer patients | – | –Patients having unilateral, bilateral immediate or delayed TRAM flaps who are discharged 18 hours postoperatively |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Reconstructive breast cancer patients
Key inclusion criteria (3 listed)
- Women undergoing any type of TRAM flap
- Age<75 yrs
- Non-smoker
Key exclusion criteria (5 listed)
- History of chronic pain or psychiatric disturbance
- History of chronic use of opioid medications
- Allergy to local anesthesia or opioid medication
- Inability to communicate in English
- BMI>35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27
Time frame: On average between 18 and 24 hours postoperatively
The patient will be met with by the study coordinator, just before discharge to administer the Quality of Recovery Questionnaire (QoR27)
The primary outcome measure is the quality of recovery post operatively, as assessed by the QoR27
Time frame: on average between 48-72 hours postoperatively
The patient will be contacted by the study coordinator, 2 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)
The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27
Time frame: On average 72-96 hours post operatively
The patient will be contacted by the study coordinator, 4 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)
The primary outcome measure is the quality of recovery post operatively as assessed by the QoR27
Time frame: On average 7-8 days postoperatively
The patient will be contacted by the study coordinator, 7 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)
1 secondary outcome
The secondary outcome measure is the quality of recovery as assessed by the VAS pain score
Time frame: This outcome will be done at the exact same time as the measurements of Quality of Recovery listed above
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
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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.
John L Semple, MD, MSc, FRCSC, FACS principal investigator
Women's College Hospital
Pamela J Morgan, MD, CCFP, FRCPC study director
Women's College Hospital
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 Breast Diseases, run by Women's College Hospital at 1 site in Canada.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Nov 2013. 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 Canada. 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?
Results are not available in the source record.
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?
The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27 (time frame: On average between 18 and 24 hours postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2013.