NCT06638645

Brief Summary

In this study, the reasons for prolonged hospital stay after thoracoscopic (video- or robot-assisted) anatomical lung resections are investigated. Currently, whenever possible, these anatomical lung resections are performed thoracoscopically, as they offer significant improvements in terms of postoperative pain, number of postoperative complications, rehabilitation, tolerance for adjuvant chemotherapy, and length of hospital stay. The development of an 'Enhanced Recovery After Surgery' (ERAS) protocol for lung surgery has further reduced hospital stay and the need for opioids for analgesia. Despite the optimal implementation of the ERAS protocol, there are still patients who need to stay in the hospital longer than the median. The aim of this research is to investigate the reasons for this.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

October 1, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

November 12, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

October 1, 2024

Last Update Submit

January 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay (days)

    The primary objective is to investigate the length of hospital stay of patients undergoing minimally invasive thoracoscopic anatomical lung resection with peri-operative care according to the Enhanced Recovery After Surgery (ERAS) protocol for lung surgery

    immediately after surgery until hospital discharge (1 week on average), up to 3 months

Secondary Outcomes (2)

  • Reasons for delayed discharge (more than 2 days postoperatively) identified through daily questionnaires and review of medical records.

    immediately after surgery until hospital discharge (1 week on average), up to 3 months

  • Number, frequency and severity of postoperative complications during hospital stay.

    immediately after surgery until hospital discharge (1 week on average), up to 3 months

Study Arms (1)

Patients undergoing a minimally invasive anatomical lung resection

Patients undergoing a minimally invasive anatomical lung resection, receiving perioperative care according to the ERAS protocol for Lung Surgery

Procedure: VATS/RATS anatomical lung resection

Interventions

Perioperative care according to the ERAS protocol for lung surgery

Also known as: VATS lobectomy, RATS lobectomy, VATS segmentectomy, RATS segmentectomy
Patients undergoing a minimally invasive anatomical lung resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for thoracoscopic anatomical lung resection. An estimated 136 patients should be included after power calculation

You may qualify if:

  • Patients referred for elective minimally invasive (uniportal or multiportal video- or robot-assisted) anatomical lung resection (lobectomy or segmentectomy)
  • Informed consent obtained pre-operatively
  • Age 18 years or older

You may not qualify if:

  • Patients younger than 18 years old
  • Traumatic event as indication for lung resection
  • Non-anatomical lung resections
  • Thoracotomy
  • Patients already hospitalized for other pathologies, pre-existent and not related to the lung surgery
  • Urgent/emergency procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

RECRUITING

Ghent University Hospital

Ghent, Belgium

RECRUITING

MeSH Terms

Conditions

Postoperative ComplicationsPain, Postoperative

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Liesbeth Desender, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 15, 2024

Study Start

November 12, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 15, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations