Randomized Study on Effects of Uniportal VATS Versus Triportal VATS

Study Overview
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Brief Summary
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For the treatment of stage I-II NSCLC, two mini-invasive techniques are mostly utilized: uni-portal and three-portal VATS. In the uniportal approach, the injury on a single intercostal space could determine a lower level of pain than the three-portal approach, allowing a better postoperative course. Few studies in Literature compare these techniques, and most of them are retrospective. The main purpose of this randomized study is to compare uni-portal VATS with three-portal VATS, in terms of postoperative pain. Secondary objectives of the study are valutations of: respiratory and functional capacity between the two groups operative time number of resected lymphnodes intra and postoperative complications, such as conversions to open surgery, amount of bleeding, prolonged air leaks, surgical site infections, pulmonary complications.

Detailed Description
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Randomized cohort clinical trial, prospectic, monocentric. Procedure of randomization: the day before the operation, with the Random Allocation Rule technique Arm 1: pulmonary lobectomy and lymphoadenectomy with uni-portal VATS approach Arm 2: pulmonary lobectomy and lymphoadenectomy with three-portal VATS approach Misurations Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation. The choice of cumulative analgesic consumption as parameter of primary outcome is because pain valuation with VAS is significantly affected by individual variability. Secondary outcomes: measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery. A pain score will be assigned to each patient after the total amount of NRS. Respiratory function will be valuated with spirometry after 7 and 30 days from surgery, and compared with pre-operative tests. All intraoperative parameters will be compared between the two groups: operative time (skin to skin), proportion of conversions to open surgery, number of resected lymphnodes, amount of bleeding. Postoperative complications will be analyzed: rate of prolonged air leaks, surgical site infections, cardiac rythhm disfunctions, pulmonary complications, post-thoracotomy syndrome, as well as lenght of stay at the hospital.

Official Title
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Randomized Study on Effects of Uniportal VATS Versus Triportal VATS for the Treatment of Stage I-II NSCLC

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: VATS uni-portal lobectomy and lymphoadenectomy
* Procedure: VATS three-portal lobectomy and lymphoadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with cT1-2N0-1M0 NSCLC, maximum diameter 5cm ASA (American Society of Anestesiology) score 1-2-3 Exclusion Criteria: N2-N3 disease Induction chemotherapy Thoracic wall infiltration Previous thoracic surgery Important pleural adhesions Severe COPD, asthma, interstitial lung disease - Liver, kidney or cardiac failure Clotting disorders Analgesic allergy Sublobar resection, sleeve lobectomy, pneumonectomy Chronic analgesic, oppioids or cortisonic use Absence of informed consent

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Uni-portal VATS<br>VATS uni-portal lobectomy and lymphoadenectomy | Procedure: VATS uni-portal lobectomy and lymphoadenectomy<br>* VATS uni-portal lobectomy and lymphoadenectomy<br>|
| Three-portal VATS<br>VATS three-portal lobectomy and lymphoadenectomy | Procedure: VATS three-portal lobectomy and lymphoadenectomy<br>* VATS three-portal lobectomy and lymphoadenectomy, Copenhagen approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of postoperative pain after uni-portal and three-portal VATS | Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery. | A pain score will be assigned to each patient after the total amount of NRS | 30 days | 
| Valuation of respiratory function | Spirometry after 7 and 30 days from surgery, compared with pre-operative tests | 30 days | 
| Intraoperative parameters | Operative time (skin to skin, minutes) | 1 day | 
| Intraoperative bleeding | Amount of bleeding | 1 day | 
| Postoperative air leakage | Rate of prolonged air leaks | 15 days | 
| Postoperative complications | Cardiac rythhm disfunctions | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary lobectomy, Uniportal, Postoperative pain, Thoracic surgery, VATS