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NCT Number: NCT03240250

Randomized Study on Effects of Uniportal VATS Versus Triportal VATS

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasms

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Thoracic Surgery Unit - Fondazione IRCCS Ca' Granda Policlinico

Milan, Mi, 20100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VATS uni-portal lobectomy and lymphoadenectomy

Procedure

VATS uni-portal lobectomy and lymphoadenectomy

VATS three-portal lobectomy and lymphoadenectomy

Procedure

VATS three-portal lobectomy and lymphoadenectomy, Copenhagen approach

Primary outcomes

  1. Measurement of postoperative pain after uni-portal and three-portal VATS

    Time frame: 7 days

    Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation.

Secondary outcomes

  1. Measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery.

    Time frame: 30 days

    A pain score will be assigned to each patient after the total amount of NRS

  2. Valuation of respiratory function

    Time frame: 30 days

    Spirometry after 7 and 30 days from surgery, compared with pre-operative tests

  3. Intraoperative parameters

    Time frame: 1 day

    Operative time (skin to skin, minutes)

  4. Intraoperative bleeding

    Time frame: 1 day

    Amount of bleeding

  5. Postoperative air leakage

    Time frame: 15 days

    Rate of prolonged air leaks

  6. Postoperative complications

    Time frame: 1 month

    Cardiac rythhm disfunctions

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2017
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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