ThOracoscopic Wedge Resection Treated With Chest Tube Removal Intraoperatively

NCT02829736 | Unknown DMC

• 1 other identifier: H-16028354
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Chest tubes are used routinely although preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal. Previous studies are however either retrospective or mainly concerning benign disease. Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, better pulmonary function and similar complication profile than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.

Conditions

Pain; Decreased Lung Function; Delayed Discharge

Keywords

lung neoplasm; lung metastasis; enhanced recovery after surgery; fast-track surgery; intraoperative chest tube removal; pain; lung function; reasons for admission

Outcome Measures

Primary Outcomes (1)

• Pain

  Average pain expressed as area under the curve from a numeric rank score at 1, 3, 6 and 9 hours after surgery as well as daily at 8 am and 8 pm from post-operative day 1 until discharge.

  Through post-operative admission, an average of 1 day.

Secondary Outcomes (5)

• Reasons for post-operative admission

  Through post-operative admission, an average of 1 day.

• Lung function

  Up to post-operative day 1.

• Reinsertion of chest tubes

  Up to post-operative day 30.

• Pneumothorax

  Up to post-operative day 1.

• Complications

  Up to post-operative day 30.

Study Arms (2)

Chest tube group

ACTIVE COMPARATOR

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

Procedure: Intraoperative sealing test; Procedure: Standard post-operative chest tube

No chest tube group

EXPERIMENTAL

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

Procedure: Intraoperative sealing test; Procedure: Intraoperative chest tube removal

Interventions

Intraoperative sealing test PROCEDURE

A standard 28 Fr chest tube is inserted through the anterior port hole and all port holes are 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.

Chest tube group; No chest tube group

Standard post-operative chest tube PROCEDURE

A regular chest tube is left in the pleura.

Chest tube group

Intraoperative chest tube removal PROCEDURE

Chest tube is removed intraoperatively.

No chest tube group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective thoracoscopic wedge resection
• Speaks and understands Danish
• FEV1 \>= 60% of expected

You may not qualify if:

• Increased risk of air leak evaluated by surgeon (large adhesions, bullae, emphysema, deep resection, etc.)
• Increased risk of bleeding evaluated by surgeon (high INR, anticoagulation not paused, large bleeding, etc.)
• Air leak on intraoperative sealing test
• Patients previously included in study
• Planned intraoperative frozen section with possible lobectomy
• Previously included in current study
• Planned frozen section diagnostics
• Previous ipsilateral anatomic lung resection

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Pain; Respiratory Insufficiency; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases

Study Officials

• Henrik J. Hansen, MD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• René H. Petersen, MD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• Henrik Kehlet, DMSc

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• Bo L. Holbek, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo L. Holbek, MD

CONTACT

+4535458429; bo.laksafoss.holbek@regionh.dk

Henrik J. Hansen, MD

CONTACT

+4535450532; henrik.jessen.hansen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Randomization occurs after ended surgery, thus masking allocation to the personnel and participant. After Randomization, there is no masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 12, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)