NCT03024294

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

2.9 years

First QC Date

January 6, 2017

Last Update Submit

July 12, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From date of consent until midnight of post op day 3

Study Arms (1)

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.

Other: Post-operative care pathway for patients undergoing VATS lobectomy or segmentectomy

Interventions

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.

Patients undergoing VATS lobectomy or segmentectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects
  • Age ≥ 18 years
  • Subjects planned to undergo a VATS lobectomy or segmentectomy procedure for lung nodules

You may not qualify if:

  • Subjects who cannot undergo VATS surgery
  • Subjects undergoing any kind of resection in addition to VATS Lobectomy or Segmentectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Mastectomy, Segmental

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Study Officials

  • Scott Swanson, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 18, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 16, 2018

Record last verified: 2018-07

Locations