Early Stage Non-small-cell Lung Cancer (Stage 1-2) Clinical Trial
Official title:
Ergonomical Assessment of Three-Dimensional Versus Two-Dimensional Thoracoscopic Lobectomy for Lung Cancer
| Verified date | April 2020 |
| Source | University of Rome Tor Vergata |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Video-assisted thoracic surgery (VATS) pulmonary lobectomy is currently widely employed as
the first treatment option for surgical management of early stage (stage I-II)
non-small-cell-lung-cancer (NSCLC).
Thanks to recent technological advances in high definition display systems, three dimensional
VATS (3D) has been developed in an attempt of overcoming some optical limits of two
dimensional (2D) VATS.
In this single center randomized trial our aim is to comparatively assess ergonomics of 3D
versus 2D VATS lobectomy for early stage NSCLC.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | December 31, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Clinical NSCLC early stage (stage I-II). - Both forced expiratory volume in one second (FEV1) and diffusion capacity of carbon monoxide (DLCO)>60% - Both predicted postoperative (PPO) FEV1 and PPO DLCO >35% - American Society of Anesthesia (ASA) score<=2 - Body mass index (BMI) >18 <28 Exclusion Criteria: - Clinical NSCLC stage> II - History of Neoadjuvant chemotherapy or radiotherapy - Radiologic evidence of extensive pleural adhesions. - Age <18 or >80 years. - Patients with previous pleurodesis or thoracotomy in the affected hemithorax. - Patients who will undergo surgical lung resection other than lobectomy. - Patients with severe comorbidity contraindicating lobectomy. - Patients refusal or noncompliance to general surgery and one-lung ventilation. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Policlinico Tor Vergata University | Roma |
| Lead Sponsor | Collaborator |
|---|---|
| University of Rome Tor Vergata |
Italy,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | a difference =10% in the score calculated for the maneuvring ergonomical domain. | 3 ergonomical domains: exposure, instrumentation and maneuvering are assessed by 4 thoracic surgeons using a new scoring scale (score range 1, unsatisfactory to 3 excellent). Primary outcome is a difference =10% (sd=0.3) in at least one of the evaluated domains. | one week after surgery | |
| Secondary | Operative time | Total duration (min) of the surgical procedure from first incision opening to last incision closure | during surgery | |
| Secondary | intraoperative bleeding | Total amount of blood (mL) lost during the surgical procedure | intraoperative | |
| Secondary | postoperative drainage volume | Total amount of fluid (mL) collected through the chest drain during in-hospital stay | two weeks after surgery | |
| Secondary | surgical mortality | Fatal complications occurryng within 90 days after surgery | 90 days after surgery | |
| Secondary | complications | Any adverse event recorded perioperatively or after the surgical procedure during in-hospital stay | 30 days after surgery | |
| Secondary | hospital stay | Overall duration (days) of in-hospital stay after the surgical procedure | 30 days after surgery | |
| Secondary | a difference =10% in the score calculated for the exposure ergonomical domain. | 3 ergonomical domains: exposure, instrumentation and maneuvering are assessed by 4 thoracic surgeons using a new scoring scale (score range 1, unsatisfactory to 3 excellent). Primary outcome is a difference =10% (sd=0.3) in at least one of the evaluated domains. | one week after surgery | |
| Secondary | a difference =10% in the score calculated for the instrumentation ergonomical domain. | 3 ergonomical domains: exposure, instrumentation and maneuvering are assessed by 4 thoracic surgeons using a new scoring scale (score range 1, unsatisfactory to 3 excellent). Primary outcome is a difference =10% (sd=0.3) in at least one of the evaluated domains. | one week after surgery |