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Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection (CREATOR)

Primary Purpose

Lung Neoplasms, Lung Surgery, Enhanced Recovery After Surgery

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Intraoperative air leak test

Intraoperative chest drain removal

Standard chest drain placement

About this trial

This is an interventional treatment trial for Lung Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18 years.
Patients referred for elective three port video-assisted thoracoscopic surgery wedge resection of the lung for suspected or confirmed malignant nodules.
first second forced expiratory volume ≥60% of expected.
No increased bleeding risk (e.g. preoperative international normalized ratio >2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy).
Not scheduled for frozen section pathology of wedge resection and subsequent lobectomy.
Able and willing to give informed consent.

Exclusion Criteria:

Increased risk of post-operative air leak assessed perioperatively by the surgeon (e.g. severe adhesions, bullous/emphysematous lung tissue, defects of the visceral pleura due to iatrogenic or other reasons, suturing in the lung tissue, deep lung resection).
Increased risk of post-operative bleeding assessed perioperatively by the surgeon (e.g. intraoperative bleeding or oozing).
Air leak during intraoperative air leak test.

Sites / Locations

Thomas Decker Christensen
RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drain-free group

Chest drain group

Arm Description

Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.

Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard postoperative chest tube.

Outcomes

Primary Outcome Measures

Acute Pain

Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire at 3 and 6 hours after surgery, and on the morning of postoperative day 1 at 8 a.m

Rescue analgesics

The amount of rescue analgesics given assessed as cumulative amount of morphine during the first 24 hours after surgery milligram equivalents (MME) as defined by pro.medicine.dk hosted by the Danish Association of the Pharmaceutical Industry

Secondary Outcome Measures

Pneumothorax

Number and size of pneumothorax at 6 hours after surgery in the drain-free group, 2 hours after drain removal in the drain group, and postoperative 2-week for both

Complications

Surgical and medical complications including mortality

Chest drain reinsertion

Number and reasons of chest drain reinsertion

Length of stay

Days in hospital after index surgery

Time to fulfilled discharge criteria

Days to meet discharge criteria but stay in hospital

Readmission

Number and reasons of readmissions

Quality of recovery after surgery

Evaluate patients' quality of life by questionnaire before surgery, at the first day after surgery

Standard analgesics given

Number of patients who did not receive planned postoperative analgesics according to the standards at their institution

Persistent pain

Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire from postoperative day 2 to 6.

Full Information

NCT ID

NCT05358158

First Posted

April 28, 2022

Last Updated

August 28, 2023

Sponsor

Rigshospitalet, Denmark

Collaborators

Aarhus University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05358158

Brief Title

Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection

Acronym

CREATOR

Official Title

Efficacy of Avoiding Chest Drain After Video-assisted Thoracoscopic Surgery Wedge Resection

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 4, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Chest drain is used routinely after lung surgery. Despite preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal, these are either retrospective or mainly concerning benign disease. Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, reduced opioid usage without increasing postoperative complications than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms, Lung Surgery, Enhanced Recovery After Surgery, Fast-track Surgery, Pain, Opioid Use, Remission

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Drain-free group

Arm Type

Experimental

Arm Description

Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.

Arm Title

Chest drain group

Arm Type

Active Comparator

Arm Description

Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard postoperative chest tube.

Intervention Type

Procedure

Intervention Name(s)

Intraoperative air leak test

Intervention Description

A standard 28 Fr chest drain is inserted through the anterior port hole with all port holes closed. With the tip of the chest tube below water, the pleura is emptied from air during continuous ventilation of the lungs. An air leak after 5 minutes of ventilation indicates a negative sealing test, whereas a cessation of air leak within 5 minutes indicates a positive sealing test.

Intervention Type

Procedure

Intervention Name(s)

Intraoperative chest drain removal

Intervention Description

Chest drain is removed intraoperatively.

Intervention Type

Procedure

Intervention Name(s)

Standard chest drain placement

Intervention Description

Chest drain is left in pleura.

Primary Outcome Measure Information:

Title

Acute Pain

Description

Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire at 3 and 6 hours after surgery, and on the morning of postoperative day 1 at 8 a.m

Time Frame

Up to postoperative day 1

Title

Rescue analgesics

Description

Time Frame

Up to postoperative day 1

Secondary Outcome Measure Information:

Title

Pneumothorax

Description

Number and size of pneumothorax at 6 hours after surgery in the drain-free group, 2 hours after drain removal in the drain group, and postoperative 2-week for both

Time Frame

Up to postoperative 2 weeks

Title

Complications

Description

Surgical and medical complications including mortality

Time Frame

Up to postoperative day 30

Title

Chest drain reinsertion

Description

Number and reasons of chest drain reinsertion

Time Frame

Up to postoperative day 30

Title

Length of stay

Description

Days in hospital after index surgery

Time Frame

Through post-operative discharge, an average of 2 days

Title

Time to fulfilled discharge criteria

Description

Days to meet discharge criteria but stay in hospital

Time Frame

Through post-operative discharge, an average of 2 days

Title

Readmission

Description

Number and reasons of readmissions

Time Frame

Through post-operative admission, an average of 7 days

Title

Quality of recovery after surgery

Description

Evaluate patients' quality of life by questionnaire before surgery, at the first day after surgery

Time Frame

Up to postoperative day 1

Title

Standard analgesics given

Description

Number of patients who did not receive planned postoperative analgesics according to the standards at their institution

Time Frame

Up to postoperative 2 weeks

Title

Persistent pain

Description

Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire from postoperative day 2 to 6.

Time Frame

Up to postoperative day 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 years. Patients referred for elective three port video-assisted thoracoscopic surgery wedge resection of the lung for suspected or confirmed malignant nodules. first second forced expiratory volume ≥60% of expected. No increased bleeding risk (e.g. preoperative international normalized ratio >2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy). Not scheduled for frozen section pathology of wedge resection and subsequent lobectomy. Able and willing to give informed consent. Exclusion Criteria: Increased risk of post-operative air leak assessed perioperatively by the surgeon (e.g. severe adhesions, bullous/emphysematous lung tissue, defects of the visceral pleura due to iatrogenic or other reasons, suturing in the lung tissue, deep lung resection). Increased risk of post-operative bleeding assessed perioperatively by the surgeon (e.g. intraoperative bleeding or oozing). Air leak during intraoperative air leak test.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lin Huang, MD

Phone

+4531478812

lin.huang@regionh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

René H Petersen, MD, PhD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Thomas D Christensen, MD, PhD

Organizational Affiliation

Aarhus University Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Bo L Holbek, MD, PhD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Morten Bendixen, MD, PhD

Organizational Affiliation

Aarhus University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jonas J Rasmussen, MD

Organizational Affiliation

Aarhus University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Henrik Kehlet, MD, PhD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Henrik J Hansen, MD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thomas Decker Christensen

City

Aarhus

State/Province

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Individual Site Status

Active, not recruiting

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lin Huang

Phone

+4531478812

lin.huang@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD

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Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection

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