Pain Clinical Trial
— CREATOROfficial title:
Efficacy of Avoiding Chest Drain After Video-assisted Thoracoscopic Surgery Wedge Resection
NCT number | NCT05358158 |
Other study ID # | H-21012837 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 4, 2022 |
Est. completion date | March 17, 2024 |
Verified date | March 2024 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 94 |
Est. completion date | March 17, 2024 |
Est. primary completion date | March 17, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Thomas Decker Christensen | Aarhus | Aarhus N |
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Aarhus University Hospital |
Denmark,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Up to postoperative day 1 | |
Primary | 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 | Up to postoperative day 1 | |
Secondary | 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 | Up to postoperative 2 weeks | |
Secondary | Complications | Surgical and medical complications including mortality | Up to postoperative day 30 | |
Secondary | Chest drain reinsertion | Number and reasons of chest drain reinsertion | Up to postoperative day 30 | |
Secondary | Length of stay | Days in hospital after index surgery | Through post-operative discharge, an average of 2 days | |
Secondary | Time to fulfilled discharge criteria | Days to meet discharge criteria but stay in hospital | Through post-operative discharge, an average of 2 days | |
Secondary | Readmission | Number and reasons of readmissions | Through post-operative admission, an average of 7 days | |
Secondary | Quality of recovery after surgery | Evaluate patients' quality of life by questionnaire before surgery, at the first day after surgery | Up to postoperative day 1 | |
Secondary | Standard analgesics given | Number of patients who did not receive planned postoperative analgesics according to the standards at their institution | Up to postoperative 2 weeks | |
Secondary | Persistent pain | Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire from postoperative day 2 to 6. | Up to postoperative day 6 |
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