Why in Hospital After VATS Lobectomy

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT04294108
Collaborator
(none)
160
1
17
9.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Prolong in-hospital stay

Study Design

Study Type:
Observational
Actual Enrollment :
160 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Why Are Patients Still in Hospital After Video-Assisted Thoracoscopic Surgery Lobectomy?
Actual Study Start Date :
Apr 20, 2020
Actual Primary Completion Date :
Dec 18, 2020
Actual Study Completion Date :
Sep 18, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Length of postoperative hospital stay [Through study completion, an average of 2 days]

Secondary Outcome Measures

  1. Number and frequency of postoperative complications [Up to 30 days]

  2. Numeric rating scale for postoperative pain in hospitalization [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.

  3. Drainage duration [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients referred to elective VATS lobectomy

  • Speaks and understands Danish

  • Informed consent obtained

Exclusion Criteria:

•Age < 18 years

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rigshospitalet Copenhagen Denmark 2100

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Lin Huang, MD, Rigshospitalet, Denmark
  • Study Director: Henrik Kehlet, MD, DMSc, Rigshospitalet, Denmark
  • Study Chair: Rene H Petersen, MD, PhD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Lin Huang, Medical Doctor/ Research Fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT04294108
Other Study ID Numbers:
  • H-20014489
First Posted:
Mar 3, 2020
Last Update Posted:
Nov 3, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lin Huang, Medical Doctor/ Research Fellow, Rigshospitalet, Denmark
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2021