Prolonged Hospital Stay After Thoracoscopic Anatomical Lung Resections (PROTRACT)

Reasons for Prolonged Hospital Stay After Thoracoscopic Anatomical Lung Resections

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Lobectomy; Postoperative Complication; VATS; Air Leakage; Minimally Invasive Surgical Procedures; Pulmonary Segmentectomy; Pain Postoperative; RATS Surgery
• Intervention / Treatment: Procedure: VATS/RATS anatomical lung resection

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Liesbeth Desender, MD, PhD; Phone Number: 3293326148; Email: liesbeth.desender@uzgent.be

Study Locations

• Belgium
  • Bruges, Belgium
    • Recruiting
    • AZ Sint-Jan Brugge-Oostende AV
    • Contact: Jan Lesaffer, MD; Phone Number: 3250452560; Email: jan.lesaffer@azsintjan.be
    • Contact: Jan Lesaffer, MD
  • Ghent, Belgium
    • Recruiting
    • Ghent University Hospital
    • Contact: Liesbeth Desender, MD, PhD; Phone Number: 3293326148; Email: liesbeth.desender@uzgent.be
    • Contact: Lauren Villeirs, MD; Email: lauren.villeirs@ugent.com
    • Contact: Lauren Villeirs, MD
    • Contact: Liesbeth Desender, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Perioperative care according to the ERAS protocol for lung surgery; Other Names: VATS lobectomy; RATS lobectomy; VATS segmentectomy; RATS segmentectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reasons for delayed discharge (more than 2 days postoperatively) identified through daily questionnaires and review of medical records.	Postoperative pain (NRS); Postoperative nausea and vomiting (yes/no); Air leak duration (days)	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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: AZ Sint-Lucas Brugge

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pain, Postoperative; Postoperative Complications
• Other Study ID Numbers: THE-2024-0246

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
• product manufactured in and exported from the U.S.: No