Why in Hospital After VATS Lobectomy

November 2, 2021 updated by: Lin Huang, Rigshospitalet, Denmark

Why Are Patients Still in Hospital After Video-Assisted Thoracoscopic Surgery Lobectomy?

The study aims to identify specific or potential reasons that prolong the length of hospital stay after video-assisted thoracoscopic surgery lobectomy.

The hypothesis is that patients who are still in hospital after video-assisted thoracoscopic surgery lobectomy are associated with prolonged air leak, infection, pneumonia, atrial fibrillation or other complications or social factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients underwent VATS lobectomy and writing informed consent.

Description

Inclusion Criteria:

  • Patients referred to elective VATS lobectomy
  • Speaks and understands Danish
  • Informed consent obtained

Exclusion Criteria:

•Age < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients underwent VATS lobectomy
All consecutive patients scheduled for video-assisted thoracoscopic surgery lobectomy.
Other: Prolong in-hospital stay
Patients have a longer length of hospital stay than the common recommendation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of postoperative hospital stay
Time Frame: Through study completion, an average of 2 days
Through study completion, an average of 2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and frequency of postoperative complications
Time Frame: Up to 30 days
Up to 30 days
Numeric rating scale for postoperative pain in hospitalization
Time Frame: Through study completion, an average of 2 days
Patients are scored using a numeric rating scale ranging from 0 (no pain) to 10 (excruciating pain) per day.
Through study completion, an average of 2 days
Drainage duration
Time Frame: Duration from postoperative chest tube placement to potential removal, an average of 2 days
The criteria of drain removal is that air leak was consistently below 20 ml/min for at least 12 hours and fluid production was non-bloody and non-chylous without an upper volume limit.
Duration from postoperative chest tube placement to potential removal, an average of 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Director: Henrik Kehlet, MD, DMSc, Rigshospitalet, Denmark
  • Study Chair: René H Petersen, MD, PhD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Actual)

December 18, 2020

Study Completion (Actual)

September 18, 2021

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

February 29, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20014489

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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