Randomized Study on Effects of Uniportal VATS Versus Triportal VATS

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240250
• Other study ID #: 3564
• Status: Completed
• Start date: March 12, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: August 2017
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• VATS uni-portal lobectomy and lymphoadenectomy
VATS uni-portal lobectomy and lymphoadenectomy
• VATS three-portal lobectomy and lymphoadenectomy
VATS three-portal lobectomy and lymphoadenectomy, Copenhagen approach

Locations

Country	Name	City	State
Italy	Thoracic Surgery Unit - Fondazione IRCCS Ca' Granda Policlinico	Milan	Mi

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Valuation of respiratory function	Spirometry after 7 and 30 days from surgery, compared with pre-operative tests	30 days
Secondary	Intraoperative parameters	Operative time (skin to skin, minutes)	1 day
Secondary	Intraoperative bleeding	Amount of bleeding	1 day
Secondary	Postoperative air leakage	Rate of prolonged air leaks	15 days
Secondary	Postoperative complications	Cardiac rythhm disfunctions	1 month