Office Based Hand Surgery Using WALANT (Wide Awake Local... | NCT02807571

Studies
Office Based Hand Surgery Using WALANT (Wide Awake Local Anesthesia No Tourniquet): Outcomes and Cost Savings Analysis

NCT02807571

Sponsor

Corewell Health West

Status

Withdrawn

Last Update Posted

Sep 22, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Surgery

Interventions

Wide Awake Local Anesthesia No Tourniquet

Countries

United States

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study underwent major protocol changes prior to planned enrollment

Expanded Access Info

Start Date

Feb 10, 2017Actual

Primary Completion Date

Oct 3, 2017Actual

Completion Date

Oct 3, 2017Actual

First Submitted Date

Jun 14, 2016

First Submission Date that Met QC Criteria

Jun 16, 2016

First Posted Date

Jun 21, 2016Estimated

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

Sep 21, 2023

Last Update Posted Date

Sep 22, 2023Actual

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

This study is aimed at determining if office based surgery is an effective way of cutting health care cost while maintaining patient safety and satisfaction.

Detailed Description

The study is a retrospective chart review with prospective patient satisfaction and functional outcome surveys.

Patients that have had office based procedures that otherwise could be performed in the outpatient surgical setting from January 1, 2015 to December 4, 2015 will be contacted for study enrollment. Patient satisfaction and functional outcome surveys will be administered to those patients that consent to the research study.

The data to be collected will include but is not limited to: age gender limb dominance, complications and co-morbidities.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Wide Awake Local Anesthesia No Tourniquet	Procedure	Wide Awake Local Anesthesia No Tourniquet for office based hand surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complication Rates	Collect the incidence of complications.	2 months

Secondary Outcomes

Measure	Description	Time Frame
Cost savings	Compare the costs of the WALANT procedure with similar procedures done at an ASC or as an outpatient.	2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients seen for office based procedures that otherwise would be performed in the outpatient surgical setting from January 1, 2015 to December 4, 2015

Exclusion Criteria:

K-wire hardware removal
Closed reductions
Patients receiving antibiotics at the time of the procedure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Consecutive patients seen for office based procedures that otherwise would be performed in the outpatient surgical setting from January 1, 2015 to December 4, 2015.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Jebson, MD	Corewell Health West	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Spectrum Health		Grand Rapids	Michigan	49503	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided