AbdominoplastyNCT01389635
Abdominoplasty Under Epidural Anesthesia
An observational study of Abdominoplasty, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Abdominoplasty is one of the most popular body-contouring procedures, yet it is also among the most hazardous aesthetic procedures currently performed. It was shown, in many studies, to be associated with a significant complication rate, some of which are life-threatening. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominoplasty
- How many people
- 31 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2009to Apr 2009
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients that underwent abdominoplasty between January 2003 and March 2008 in a private hospital by Dr. Yitshak Ramon.
Who may be able to join
- All patients that underwent abdominoplasty between January 2003 and March 2008 in a private hospital by Dr. Yitshak Ramon.
Who cannot join
- Patients with concurrent operations requiring general anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Abdominoplasty Under Epidural Anesthesia: Safer for the Patient, Easier for the Surgeon.
Abdominoplasty is one of the most popular body-contouring procedures, yet it is also among the most hazardous aesthetic procedures currently performed. It was shown, in many studies, to be associated with a significant complication rate, some of which are life-threatening. This study describes the investigators experience with a series of abdominoplasties performed under epidural anesthesia. Outcomes are presented, especially in terms of complication, and the practical advantages of this method are discussed.
- Conditions
- Abdominoplasty
- Keywords
- Abdominoplasty, Epidural
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 |
|---|---|---|
| Abdominoplasty patients | All patients who underwent abdominoplasty at our institution without concurrent operations |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startMar 2009
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbdominoplastyStudies 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
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Yitshak Ramon, MD, Principal investigator, Plastic Surgery Department, Rambam Healthcare Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389635
- Sponsor's protocol ID
- 0019-11-RMB-CTIL
- Status last verified
- Jul 2011
- First submitted
- 6 Jul 2011
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominoplasty Under Epidural Anesthesia: Safer for the Patient, Easier for the Surgeon.
- ClinicalTrials.gov ID
- NCT01389635
- Acronym / sponsor ID
- 0019-11-RMB-CTIL
- Conditions
- Abdominoplasty
- Keywords
- Abdominoplasty, Epidural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 8 Jul 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.
Abdominoplasty is one of the most popular body-contouring procedures, yet it is also among the most hazardous aesthetic procedures currently performed. It was shown, in many studies, to be associated with a significant complication rate, some of which are life-threatening. This study describes the investigators experience with a series of abdominoplasties performed under epidural anesthesia. Outcomes are presented, especially in terms of complication, and the practical advantages of this method are discussed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominoplasty patients | – | –All patients who underwent abdominoplasty at our institution without concurrent operations |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that underwent abdominoplasty between January 2003 and March 2008 in a private hospital by Dr. Yitshak Ramon.
Key inclusion criteria (1 listed)
- All patients that underwent abdominoplasty between January 2003 and March 2008 in a private hospital by Dr. Yitshak Ramon.
Key exclusion criteria (1 listed)
- Patients with concurrent operations requiring general anesthesia.
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 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 8 Jul 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.
Yitshak Ramon, MD principal investigator
Plastic Surgery Department, Rambam Healthcare Campus
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 Abdominoplasty, run by Rambam Health Care Campus at 1 site in Israel.
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 8 Jul 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 Israel. 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.
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 8 Jul 2011.