SurgeryWALANTNCT02807571
Office Based Hand Surgery Using WALANT (Wide Awake Local Anesthesia No Tourniquet): Outcomes and Cost Savings Analysis
An observational study of Surgery, run by Corewell Health West at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery
- What is being tested?
- Wide Awake Local Anesthesia No Tourniquet
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2017to 3 Oct 2017
- 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: 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.
Who may be able to join
- Patients seen for office based procedures that otherwise would be performed in the outpatient surgical setting from January 1, 2015 to December 4, 2015
Who cannot join
- K-wire hardware removal
- Closed reductions
- Patients receiving antibiotics at the time of the procedure
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Surgery
- Being tested
- Wide Awake Local Anesthesia No Tourniquet
- Keywords
- Hand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wide Awake Local Anesthesia No TourniquetProcedure or surgery
Wide Awake Local Anesthesia No Tourniquet for office based hand surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Rates
Collect the incidence of complications.
Measured: 2 months
Secondary outcomes (1)
Cost savings
Compare the costs of the WALANT procedure with similar procedures done at an ASC or as an outpatient.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start10 Feb 2017
- Primary completion3 Oct 2017
- Study completion3 Oct 2017
Why it stopped: Study underwent major protocol changes prior to planned enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Jebson, MD, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807571
- Sponsor's protocol ID
- 2015-263
- Acronym
- WALANT
- Status last verified
- Sep 2023
- First submitted
- 14 Jun 2016
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Office Based Hand Surgery Using WALANT (Wide Awake Local Anesthesia No Tourniquet): Outcomes and Cost Savings Analysis
- ClinicalTrials.gov ID
- NCT02807571
- Acronym / sponsor ID
- WALANT / 2015-263
- Conditions
- Surgery
- Keywords
- Hand
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study underwent major protocol changes prior to planned enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 21 Jun 2016 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- Patients seen for office based procedures that otherwise would be performed in the outpatient surgical setting from January 1, 2015 to December 4, 2015
Key exclusion criteria (3 listed)
- K-wire hardware removal
- Closed reductions
- Patients receiving antibiotics at the time of the procedure
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 |
|---|---|---|
| Wide Awake Local Anesthesia No TourniquetWide Awake Local Anesthesia No Tourniquet for office based hand surgery. | Procedure or surgery | – |
Primary outcome
Complication Rates
Time frame: 2 months
Collect the incidence of complications.
1 secondary outcome
Cost savings
Time frame: 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Peter Jebson, MD principal investigator
Corewell Health West
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 Surgery, run by Corewell Health West 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 3 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: withdrawn, as of the sponsor's last update on 22 Sep 2023. 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 withdrawn before enrolling participants, so there are no results.
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?
Complication Rates (time frame: 2 months). 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 22 Sep 2023.