VATS LobectomyNCT03024294
Care Pathway for Patients Undergoing VATS Lobectomy or Segmentectomy
A study testing Post-operative care pathway for patients undergoing VATS lobectomy or segmentectomy in people with VATS Lobectomy and VATS Segmentectomy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this study is to create a unified SOP for care of subjects undergoing VATS lobectomy and segmentectomy by members of the Division of Thoracic Surgery. Other academic centers have created standardized algorithms for the care of their subjects and this enables the centers to determine which subjects can be… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- VATS Lobectomy, VATS Segmentectomy, Care Pathway
- What is being tested?
- Post-operative care pathway for patients undergoing VATS lobectomy or segmentectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Dec 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects
- Age ≥ 18 years
- Subjects planned to undergo a VATS lobectomy or segmentectomy procedure for lung nodules
Who cannot join
- Subjects who cannot undergo VATS surgery
- Subjects undergoing any kind of resection in addition to VATS Lobectomy or Segmentectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The goal of this study is to create a unified SOP for care of subjects undergoing VATS lobectomy and segmentectomy by members of the Division of Thoracic Surgery. Other academic centers have created standardized algorithms for the care of their subjects and this enables the centers to determine which subjects can be placed on an accelerated pathway to discharge and which cannot. Some of these SOPS dictate uniform treatment algorithms with reduction in what may be unnecessary tests to simplify patient care and likely accelerate them towards safe and more timely discharge from the hospital.
Read the detailed description
This is a prospective, study to develop, test, fine-tune and refine an SOP for the post-operative care for patients who undergo a VATS lobectomy or segmentectomy performed by one of the surgeons in The Division of Thoracic Surgery. This study will be conducted in two phases. Phase 1 will be focused on early feasibility of the SOP and this will be done by enrolling 50 participants among the subgroup of Thoracic VATS Surgeons who participate. An analysis will take place upon the completion of the phase 1 to look at the percentage of participants who were able to be discharged on or prior to POD 3. Upon this analysis, modifications across all areas of the care pathway will be evaluated and altered if deemed necessary by the PI and other members of the study team. This analysis will drive any modifications needed that will be incorporated into the phase II design prior to its implementation. The treating Thoracic Surgeon for each patient will follow the SOP as it is outlined and the steps the post-operative team will follow will be dependent on which phase the participant is enrolled too. Data will be collected for each participant starting just prior to the VATS operation and continue through the discharge and conclude once the participants have reached their 90-day post-discharge date. Upon discharge from the hospital the participant will enter the follow-up period of the study.
- Conditions
- VATS Lobectomy, VATS Segmentectomy, Care Pathway, Lung Nodule
- Being tested
- Post-operative care pathway for patients undergoing VATS lobectomy or segmentectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-operative care pathway for patients undergoing VATS lobectomy or segmentectomyOther
To place participants on this specific post-operative care pathway upon the completion of their VATS surgery to determine the discharge rate by midnight on post-operative day (POD) three.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing VATS lobectomy or segmentectomy | Other | Patients undergoing VATS lobectomy or segmentectomy performed by one of the surgeons in the Division of Thoracic Surgery who are then placed on this specific post-operative care pathway to determine the rate of discharge of these patients by post-operative day (POD) three. Receives: Other: Post-operative care pathway for patients undergoing VATS lobectomy or segmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate feasibility of this SOP in two phases. The primary objective of phase 1 is to determine the POD 3 rate, defined as proportion of patients who are discharged by midnight on POD 3.
Measured: From date of consent until midnight of post op day 3
The primary objective of phase II is to further evaluate this SOP. The study team will also have the opportunity to refine and fine tune this SOP between phase I and phase II.
Measured: From date of consent until midnight of post op day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VATS LobectomyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott J Swanson, Brigham and Women's Hospital
- Investigators
- Scott Swanson, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024294
- Sponsor's protocol ID
- 2016P002308
- Status last verified
- Jul 2018
- First submitted
- 6 Jan 2017
- Last updated
- 16 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Pathway for Patients Undergoing VATS Lobectomy or Segmentectomy
- ClinicalTrials.gov ID
- NCT03024294
- Acronym / sponsor ID
- 2016P002308
- Conditions
- VATS Lobectomy, VATS Segmentectomy, Care Pathway, Lung Nodule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Jan 2017 (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 goal of this study is to create a unified SOP for care of subjects undergoing VATS lobectomy and segmentectomy by members of the Division of Thoracic Surgery. Other academic centers have created standardized algorithms for the care of their subjects and this enables the centers to determine which subjects can be placed on an accelerated pathway to discharge and which cannot. Some of these SOPS dictate uniform treatment algorithms with reduction in what may be unnecessary tests to simplify patient care and likely accelerate them towards safe and more timely discharge from the hospital.
Detailed description
This is a prospective, study to develop, test, fine-tune and refine an SOP for the post-operative care for patients who undergo a VATS lobectomy or segmentectomy performed by one of the surgeons in The Division of Thoracic Surgery. This study will be conducted in two phases. Phase 1 will be focused on early feasibility of the SOP and this will be done by enrolling 50 participants among the subgroup of Thoracic VATS Surgeons who participate. An analysis will take place upon the completion of the phase 1 to look at the percentage of participants who were able to be discharged on or prior to POD 3. Upon this analysis, modifications across all areas of the care pathway will be evaluated and altered if deemed necessary by the PI and other members of the study team. This analysis will drive any modifications needed that will be incorporated into the phase II design prior to its implementation. The treating Thoracic Surgeon for each patient will follow the SOP as it is outlined and the steps the post-operative team will follow will be dependent on which phase the participant is enrolled too. Data will be collected for each participant starting just prior to the VATS operation and continue through the discharge and conclude once the participants have reached their 90-day post-discharge date. Upon discharge from the hospital the participant will enter the follow-up period of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing VATS lobectomy or segmentectomy | Other | Other: Post-operative care pathway for patients undergoing VATS lobectomy or segmentectomyPatients undergoing VATS lobectomy or segmentectomy performed by one of the surgeons in the Division of Thoracic Surgery who are then placed on this specific post-operative care pathway to determine the rate of discharge of these patients by post-operative day (POD) three. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects
- Age ≥ 18 years
- Subjects planned to undergo a VATS lobectomy or segmentectomy procedure for lung nodules
Key exclusion criteria (2 listed)
- Subjects who cannot undergo VATS surgery
- Subjects undergoing any kind of resection in addition to VATS Lobectomy or Segmentectomy
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 |
|---|---|---|
| Post-operative care pathway for patients undergoing VATS lobectomy or segmentectomyTo place participants on this specific post-operative care pathway upon the completion of their VATS surgery to determine the discharge rate by midnight on post-operative day (POD) three. | Other | Patients undergoing VATS lobectomy or segmentectomy |
Primary outcome
The primary objective is to evaluate feasibility of this SOP in two phases. The primary objective of phase 1 is to determine the POD 3 rate, defined as proportion of patients who are discharged by midnight on POD 3.
Time frame: From date of consent until midnight of post op day 3
The primary objective of phase II is to further evaluate this SOP. The study team will also have the opportunity to refine and fine tune this SOP between phase I and phase II.
Time frame: From date of consent until midnight of post op day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
Related trials for VATS Lobectomy
Recruiting
Pre-incisional Infiltration With Ropivacaine Plus Triamcinolone for Relieving Postoperative Pain After Thoracoscopic Surgery
Video-assisted Thoracoscopic Surgery (VATS), Wedge Resection
Not yet recruiting
Effect of Inspired Oxygen Concentration on Postoperative Atelectasis After VATS Lobectomy
Atelectasis, Postoperative Pulmonary Complications
Enrolling by invitationObservational study
Evaluation of the Effectiveness of Enhanced Recovery After Surgery (ERAS) Program in Pediatric Lung Surgery
Lung Surgery, Enhanced Recovery After Surgery, ERAS
Not yet recruitingObservational study
Dynamic Prediction of Sleep Protection Demand on the First Postoperative Night and Its Influence on Ward Process After Thoracoscopic Lobectomy or Segmentectomy
Postoperative Sleep Disturbance
Recruiting
Pre-incisional Infiltration With Ropivacaine Plus Diprospan for Relieving Postoperative Pain After Thoracoscopic Surgery
Video-assisted Thoracoscopic Surgery (VATS), Wedge Resection
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.
Scott Swanson, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-operative care pathway for patients undergoing VATS lobectomy or segmentectomy in people with VATS Lobectomy and VATS Segmentectomy, run by Brigham and Women's Hospital 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Jul 2018. 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?
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.
What does the primary outcome measure?
The primary objective is to evaluate feasibility of this SOP in two phases. The primary objective of phase 1 is to determine the POD 3 rate, defined as proportion of patients who are discharged by midnight on POD 3. (time frame: From date of consent until midnight of post op day 3). The study lists 2 primary outcomes in all. 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 16 Jul 2018.