Minimally Invasive Surgical ProceduresPROTRACTNCT06638645
Prolonged Hospital Stay After Thoracoscopic Anatomical Lung Resections
An observational study of Minimally Invasive Surgical Procedures and VATS, run by University Hospital, Ghent at 2 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimally Invasive Surgical Procedures, VATS, RATS Surgery
- What is being tested?
- VATS/RATS anatomical lung resection
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 2 sitesBelgium
- Study dates
- 12 Nov 2024to 31 Dec 2025
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for thoracoscopic anatomical lung resection. An estimated 136 patients should be included after power calculation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
AZ Sint-Jan Brugge-Oostende AV
Bruges
Jan Lesaffer, MD, 3250452560, jan.lesaffer@azsintjan.be
Jan Lesaffer, MD
- Recruiting
Ghent University Hospital
Ghent
Liesbeth Desender, MD, PhD, 3293326148, liesbeth.desender@uzgent.be
Lauren Villeirs, MD, lauren.villeirs@ugent.com
About this study
Official title: 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.
- Conditions
- Minimally Invasive Surgical Procedures, VATS, RATS Surgery, Pulmonary Lobectomy, Pulmonary Segmentectomy, Air Leakage
- Being tested
- VATS/RATS anatomical lung resection
- Medical subject headings
- Postoperative Complications, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATS/RATS anatomical lung resectionProcedure or surgery
Also called VATS lobectomy, RATS lobectomy, VATS segmentectomy, RATS segmentectomy
Perioperative care according to the ERAS protocol for lung surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: VATS/RATS anatomical lung resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
- Postoperative pain (NRS)
- Postoperative nausea and vomiting (yes/no)
- Air leak duration (days)
Measured: immediately after surgery until hospital discharge (1 week on average), up to 3 months
Number, frequency and severity of postoperative complications during hospital stay.
Measured: immediately after surgery until hospital discharge (1 week on average), up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start12 Nov 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Sint-Lucas Brugge
- Responsible party
- Principal investigator, DienstThoracaleEnVasculaireHeelkunde, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638645
- Sponsor's protocol ID
- THE-2024-0246
- Acronym
- PROTRACT
- Status last verified
- Jan 2025
- First submitted
- 1 Oct 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reasons for Prolonged Hospital Stay After Thoracoscopic Anatomical Lung Resections
- ClinicalTrials.gov ID
- NCT06638645
- Acronym / sponsor ID
- PROTRACT / THE-2024-0246
- Conditions
- Minimally Invasive Surgical Procedures, VATS, RATS Surgery, Pulmonary Lobectomy, Pulmonary Segmentectomy, Air Leakage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- AZ Sint-Lucas Brugge
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing a minimally invasive anatomical lung resection | – | Procedure: VATS/RATS anatomical lung resectionPatients undergoing a minimally invasive anatomical lung resection, receiving perioperative care according to the ERAS protocol for Lung Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for thoracoscopic anatomical lung resection. An estimated 136 patients should be included after power calculation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VATS/RATS anatomical lung resectionAlso: VATS lobectomy, RATS lobectomy, VATS segmentectomy, RATS segmentectomyPerioperative care according to the ERAS protocol for lung surgery | Procedure or surgery | Patients undergoing a minimally invasive anatomical lung resection |
Primary outcome
Length of hospital stay (days)
Time frame: immediately after surgery until hospital discharge (1 week on average), up to 3 months
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
2 secondary outcomes
Reasons for delayed discharge (more than 2 days postoperatively) identified through daily questionnaires and review of medical records.
Time frame: immediately after surgery until hospital discharge (1 week on average), up to 3 months
Number, frequency and severity of postoperative complications during hospital stay.
Time frame: immediately after surgery until hospital discharge (1 week on average), up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Minimally Invasive Surgical Procedures and VATS, run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liesbeth Desender, MD, PhD (3293326148, Liesbeth.Desender@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (days) (time frame: immediately after surgery until hospital discharge (1 week on average), up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.