Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VATS three-portal lobectomy and lymphoadenectomy | Procedure | — | UNRESOLVED |
| VATS uni-portal lobectomy and lymphoadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Uni-portal VATS
- description
- VATS uni-portal lobectomy and lymphoadenectomy
- interventionNames
- Procedure: VATS uni-portal lobectomy and lymphoadenectomy
- label
- Three-portal VATS
- description
- VATS three-portal lobectomy and lymphoadenectomy
- interventionNames
- Procedure: VATS three-portal lobectomy and lymphoadenectomy
Primary outcomes (1)
- measure
- Measurement of postoperative pain after uni-portal and three-portal VATS
- timeFrame
- 7 days
- description
- Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMendogni 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. PMID 33632284