Abdominoplasty Under Epidural Anesthesia | NCT01389635

Studies
Abdominoplasty Under Epidural Anesthesia

NCT01389635

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Jul 8, 2011Estimated

Enrollment

31Actual

Phase

Not provided

Conditions

Abdominoplasty

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Mar 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Jul 6, 2011

First Submission Date that Met QC Criteria

Jul 7, 2011

First Posted Date

Jul 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2011

Last Update Posted Date

Jul 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Abdominoplasty patients		All patients who underwent abdominoplasty at our institution without concurrent operations

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients that underwent abdominoplasty between January 2003 and March 2008 in a private hospital by Dr. Yitshak Ramon.

Exclusion Criteria:

Patients with concurrent operations requiring general anesthesia.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients that underwent abdominoplasty between January 2003 and March 2008 in a private hospital by Dr. Yitshak Ramon.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yitshak Ramon, MD	Plastic Surgery Department, Rambam Healthcare Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elisha Medical Center		Haifa			Israel