Clinical trial NCT03240250: Randomized Study on Effects of Uniportal VATS Versus Triportal VATS
Official title: Randomized Study on Effects of Uniportal VATS Versus Triportal VATS for the Treatment of Stage I-II NSCLC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: VATS
Pulmonary lobectomy
Uniportal
Postoperative pain
Thoracic surgery
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with clinical diagnosis of NSCLC, stage I-II, age 30-75, who undergo pulmonary lobectomy and limphadenectomy with radical intent

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of postoperative pain after uni-portal and three-portal VATS
timeFrame: 7 days
Secondary outcomes:
measure: Measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery.
timeFrame: 30 days
measure: Valuation of respiratory function
timeFrame: 30 days
measure: Intraoperative parameters
timeFrame: 1 day
measure: Intraoperative bleeding
timeFrame: 1 day
measure: Postoperative air leakage
timeFrame: 15 days
measure: Postoperative complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Thoracic Surgery Unit - Fondazione IRCCS Ca' Granda Policlinico
state: Mi
Study officials:
affiliation: Fondazione Ca' Granda IRCCS Policlinico Milan
name: Davide Tosi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mendogni P, Mazzucco A, Palleschi A, Rosso L, Righi I, Carrinola R, Damarco F, Privitera E, Fumagalli J, Bonitta G, Nosotti M, Tosi D. Uniportal and three-portal video-assisted thoracic surgery pulmonary lobectomy for early-stage lung cancer (UNIT trial): study protocol of a single-center randomized trial. Trials. 2021 Feb 25;22(1):163. doi: 10.1186/s13063-021-05115-w.