Cardiac SurgeryNCT00229892
Incisions for Cardiac Surgery
An observational study of Cardiac Surgery and Cardiac Diseases, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
The purpose is to evaluate the investigators' length of incisions based on patient weight, operative times, hospital lengths of stay, pain medicine requirements, complications and costs. These data will lead to a new minimally invasive standard of care without a reduction in outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Surgery, Cardiac Diseases
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Sep 2006
- 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: children who have undergone cardiac surgery at Children's, Egleston, before 11.1.2004
Who may be able to join
- Children who have undergone cardiac surgery at Children's Healthcare of Atlanta
- Surgery before November 1, 2004
Who cannot join
- those who do not fall under the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
About this study
Official title: Small Incisions for Cardiac Surgery
The purpose is to evaluate the investigators' length of incisions based on patient weight, operative times, hospital lengths of stay, pain medicine requirements, complications and costs. These data will lead to a new minimally invasive standard of care without a reduction in outcomes.
Read the detailed description
There is a trend in surgery, in general, toward minimal invasion. This includes the transition to laparoscopy/thoracoscopy from open procedures, as well as the reduction in incision size for open procedures. The goal of minimally invasive techniques is to reduce morbidity and length of hospital stay, with a consequent reduction in hospital cost.
There are few cardiac operations that are currently performed with minimally invasive techniques. One of these is the repair of an atrial septal defect, which can be performed though a small skin incision and partial rather than full sternotomy. Another is the ligation of a patent ductus arteriosus, which can be performed through a muscle-sparing thoracotomy rather than a full thoracotomy.
Both of these techniques minimize the scarring and the healing time required for post-operative recovery. We need to be confident that it has not affected our outcomes adversely. We need to evaluate our length of incisions based on patient weight, operative times, hospital lengths of stay, pain medicine requirements, complications and costs.
Hopefully, these data will lead to a new minimally invasive standard of care without a reduction in outcomes.
We will review charts before November 1, 2004 at Children's Healthcare of Atlanta.
- Conditions
- Cardiac Surgery, Cardiac Diseases
- Keywords
- pediatric health, cardiac, small incisions, operations, minimally invasive
- Medical subject headings
- Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionSep 2006
Why it stopped: after 90 charts reviewed, insufficient data to support conclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Brian Kogon, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229892
- Sponsor's protocol ID
- 04-120
- Status last verified
- May 2007
- First submitted
- 13 Sep 2005
- Last updated
- 18 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Incisions for Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00229892
- Acronym / sponsor ID
- 04-120
- Conditions
- Cardiac Surgery, Cardiac Diseases
- Keywords
- pediatric health, cardiac, small incisions, operations, minimally invasive
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: after 90 charts reviewed, insufficient data to support conclusion
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Feb 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 30 Sep 2005 (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 is to evaluate the investigators' length of incisions based on patient weight, operative times, hospital lengths of stay, pain medicine requirements, complications and costs. These data will lead to a new minimally invasive standard of care without a reduction in outcomes.
Detailed description
There is a trend in surgery, in general, toward minimal invasion. This includes the transition to laparoscopy/thoracoscopy from open procedures, as well as the reduction in incision size for open procedures. The goal of minimally invasive techniques is to reduce morbidity and length of hospital stay, with a consequent reduction in hospital cost.
There are few cardiac operations that are currently performed with minimally invasive techniques. One of these is the repair of an atrial septal defect, which can be performed though a small skin incision and partial rather than full sternotomy. Another is the ligation of a patent ductus arteriosus, which can be performed through a muscle-sparing thoracotomy rather than a full thoracotomy.
Both of these techniques minimize the scarring and the healing time required for post-operative recovery. We need to be confident that it has not affected our outcomes adversely. We need to evaluate our length of incisions based on patient weight, operative times, hospital lengths of stay, pain medicine requirements, complications and costs.
Hopefully, these data will lead to a new minimally invasive standard of care without a reduction in outcomes.
We will review charts before November 1, 2004 at Children's Healthcare of Atlanta.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children who have undergone cardiac surgery at Children's, Egleston, before 11.1.2004
Key inclusion criteria (2 listed)
- Children who have undergone cardiac surgery at Children's Healthcare of Atlanta
- Surgery before November 1, 2004
Key exclusion criteria (1 listed)
- those who do not fall under the above inclusion criteria
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: after 90 charts reviewed, insufficient data to support conclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2011.
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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.
Brian Kogon, MD principal investigator
Emory University
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 Cardiac Surgery and Cardiac Diseases, run by Children's Healthcare of Atlanta 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 2 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: stopped early, as of the sponsor's last update on 18 Nov 2011. 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?
The study was stopped early (reason given: after 90 charts reviewed, insufficient data to support conclusion). 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.
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 18 Nov 2011.