Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries

NCT ID: NCT04670523

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-06

Study Completion Date

2027-12-31

Brief Summary

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The safe conditions for early chest tube removal have been progressively questioned and redefined around reliable digital air flow criteria and extension of liquid threshold accepted. Nevertheless, in current practice, the chest tube remains in restricting early mobilization and optimal compliance with ERAS programme, during the first crucial 24 h after surgery. Thus, to go further, the investigators decide to assess in this study the safety of POD 0 chest tube removal after minor thoracic operations in patients in health condition tolerating operation and anesthesia.

Detailed Description

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Chest tube management is a key element of postoperative care after thoracic surgeries for different indications. During the last decade, minimally invasive surgery and enhanced recovery after surgery (ERAS) programmes have radically changed the equation of recovery, contributing to reduce postoperative morbidity and enhance quality of life, but the chest tube remains its Achilles heel, still providing postoperative pain and impairing pulmonary function. In this view, early chest tube removal has been widely promoted not only for its economic benefits on length of stay but also for improving quality of life and potentially reducing postoperative complications. In parallel, the change from traditional chest drainage devices to electronic devices has also enabled a more accurate air leak measurement with reduction of interobserver variability, decreased chest drainage duration and shortened LOS. The safe conditions for early chest tube removal have been progressively questioned and redefined around reliable digital air flow criteria and extension of liquid threshold accepted. Nevertheless, in current practice, the chest tube remains in restricting early mobilization and optimal compliance with ERAS programme, during the first crucial 24 h after surgery. Thus, to go further, the investigators decide to assess in this study the safety of POD 0 chest tube removal after minor thoracic operations in patients in health condition tolerating operation and anesthesia.

Conditions

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Lung Pathologies of Unclear Etiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomization of patients after minor thoracic operations into two different groups. The patients of the study group are getting their chest tube removed according to our current airleak protocol (Flow \<20 mL/ min on digital suction device) but already in the operating room after wound closure. If airleak is persisting than chest tube removal will be performed according to the traditional protocol not earlier than on postoperative day 1. In the control group, the chest tube gets removed according to the investigators' traditional standard protocol not earlier than on postoperative day.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test group

Test group: The patients of the study group are getting their chest tube removed according to the investigators' current airleak protocol (Flow \<20 mL/ min on digital suction device) but already in the operating room immediately following wound closure (Postoperative day 0 (POD0)). If airleak is persisting than chest tube removal will be performed according to the traditional protocol not earlier than on postoperative day 1 (POD 1).

Group Type OTHER

Early postoperative day 0 (POD 0) chest tube removal.

Intervention Type PROCEDURE

Chest tube removal is a standard bedside intervention after lung resections. Its time point is normally defined according a traditional standard airleak threshold. Traditionally, in our department this threshold will be respected not earlier than 1 day after the operation. The patients of the study group are getting their chest tube removed according to our current airleak protocol (Flow \<20 mL/ min on digital suction device) but already in the operating room after wound closure (POD 0). If airleak is persisting than chest tube removal will be performed according to the traditional protocol not earlier than on postoperative day 1 (POD 1).

Control group

In the control group, the chest tube gets removed according to the investigators' traditional standard protocol not earlier than on postoperative day 1 (POD1).

Group Type OTHER

Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).

Intervention Type PROCEDURE

Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).

Interventions

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Early postoperative day 0 (POD 0) chest tube removal.

Chest tube removal is a standard bedside intervention after lung resections. Its time point is normally defined according a traditional standard airleak threshold. Traditionally, in our department this threshold will be respected not earlier than 1 day after the operation. The patients of the study group are getting their chest tube removed according to our current airleak protocol (Flow \<20 mL/ min on digital suction device) but already in the operating room after wound closure (POD 0). If airleak is persisting than chest tube removal will be performed according to the traditional protocol not earlier than on postoperative day 1 (POD 1).

Intervention Type PROCEDURE

Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).

Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Thoracoscopic extra-anatomical lung resection (surgical lung biopsy)
2. Thoracoscopic pleural biopsy
3. Signed consent
4. Age of majority

Exclusion Criteria

1. Anatomical resection
2. Empyema
3. Pleural effusion
4. Pleurodesis
5. Vulnerable persons (Pregnant women, Children and adolescents)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Dorn, PD

Role: STUDY_DIRECTOR

Chief, Department of General Thoracic Surgery, Inselspital

Locations

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University Hospital of Bern, Inselspital

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Patrick Dorn, PD

Role: CONTACT

0041 31 632 37 45 ext. 0797696216

Facility Contacts

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Patrick Dorn, PD

Role: primary

0041 31 632 37 45 ext. 0797696216

Other Identifiers

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EROCT

Identifier Type: -

Identifier Source: org_study_id

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