Breast CancerNCT00543764
Intraoperative Pathway in DIEP Flap Breast Reconstruction
An observational study of Breast Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Efficiency in the operating room can be difficult in long cases with multiple surgeons. We used a team based approach to develop an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- pathway
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Feb 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients undergoing breast reconstruction
Who may be able to join
- All cases prior to pathway
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Efficiency in the operating room can be difficult in long cases with multiple surgeons. We used a team based approach to develop an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.
Read the detailed description
A team based approach was developed with an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.
- Conditions
- Breast Cancer
- Being tested
- pathway
- Keywords
- Intraoperative Pathway, Breast Reconstruction, DIEP flap
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pathwayOther
Also called intraoperative pathway
Comparison of pre and post pathway
| Study group | Role | What they receive |
|---|---|---|
| Pre pathway | Pre pathway | |
| Post pathway | Post pathway Receives: Other: pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Length of Time in surgery
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startJan 2005
- Primary completionDec 2008
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernard T. Lee, Beth Israel Deaconess Medical Center
- Investigators
- Bernard T Lee, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543764
- Sponsor's protocol ID
- 2007-P-000266/1
- Status last verified
- Feb 2019
- First submitted
- 12 Oct 2007
- Last updated
- 7 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Pathway in DIEP Flap Breast Reconstruction
- ClinicalTrials.gov ID
- NCT00543764
- Acronym / sponsor ID
- 2007-P-000266/1
- Conditions
- Breast Cancer
- Keywords
- Intraoperative Pathway, Breast Reconstruction, DIEP flap
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Oct 2007 (estimated)
- Results
- Posted 6 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficiency in the operating room can be difficult in long cases with multiple surgeons. We used a team based approach to develop an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.
Detailed description
A team based approach was developed with an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre pathway | – | –Pre pathway |
| Post pathway | – | Other: pathwayPost pathway |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing breast reconstruction
Key inclusion criteria (1 listed)
- All cases prior to pathway
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| pathwayAlso: intraoperative pathwayComparison of pre and post pathway | Other | Post pathway |
Primary outcome
Operative Time
Time frame: 3 years
Length of Time in surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bernard T Lee, MD principal investigator
Beth Israel Deaconess Medical Center
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 Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 7 Mar 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Operative Time (time frame: 3 years). 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 7 Mar 2019.