Randomized Study on Effects of Uniportal VATS Versus Triportal VATS
Condition: Lung Cancer
Study type: Observational

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.
    

Intervention name(s): VATS uni-portal lobectomy and lymphoadenectomy; VATS three-portal lobectomy and lymphoadenectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): VATS uni-portal lobectomy and lymphoadenectomy; VATS three-portal lobectomy and lymphoadenectomy, Copenhagen approach
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
      
Keywords: VATS; Pulmonary lobectomy; Uniportal; Postoperative pain; Thoracic surgery