Randomized Study on Effects of Uniportal VATS Versus Triportal VATS

Completed

• Conditions: Lung Cancer
• Interventions: Procedure: VATS uni-portal lobectomy and lymphoadenectomy; Procedure: VATS three-portal lobectomy and lymphoadenectomy

• Registration Number: NCT03240250
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

Study Timeline

• Study Start: 2017-03-12
• Study First Submitted: 2017-07-13
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Uni-portal VATS	VATS uni-portal lobectomy and lymphoadenectomy	VATS uni-portal lobectomy and lymphoadenectomy
Three-portal VATS	VATS three-portal lobectomy and lymphoadenectomy	VATS three-portal lobectomy and lymphoadenectomy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Thoracic Surgery Unit - Fondazione IRCCS Ca' Granda Policlinico; 🇮🇹 Milan, Mi, Italy