Randomized Study on Effects of Uniportal VATS Versus Triportal VATS

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: VATS uni-portal lobectomy and lymphoadenectomy; Procedure: VATS three-portal lobectomy and lymphoadenectomy

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Italy
  • Mi
    • Milan, Mi, Italy, 20100
      • Thoracic Surgery Unit - Fondazione IRCCS Ca' Granda Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Uni-portal VATS; VATS uni-portal lobectomy and lymphoadenectomy	Procedure: VATS uni-portal lobectomy and lymphoadenectomy; VATS uni-portal lobectomy and lymphoadenectomy
Three-portal VATS; VATS three-portal lobectomy and lymphoadenectomy	Procedure: VATS three-portal lobectomy and lymphoadenectomy; VATS three-portal lobectomy and lymphoadenectomy, Copenhagen approach

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Investigators: Principal Investigator: Davide Tosi, Fondazione Ca' Granda IRCCS Policlinico Milan

Publications and helpful links

General Publications

• 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. Erratum In: Trials. 2022 Jul 6;23(1):549.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2017
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: VATS; Postoperative pain; Thoracic surgery; Pulmonary lobectomy; Uniportal
• Other Study ID Numbers: 3564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No