Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

Not Applicable

Completed

• Conditions: Early Stage Non-small-cell Lung Cancer (Stage 1-2)

• Registration Number: NCT03925103
• Lead Sponsor: University of Rome Tor Vergata

Brief Summary

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.

Detailed Description

Video-assisted thoracic surgery (VATS) is widely employed for pulmonary lobectomy in early stage non-small-cell-lung-cancer (NSCLC). Indeed, VATS is thought to represent an optimal minimally invasive surgical option which is deemed superior to conventional thoracotomy since it enables smaller incisions with no rib spreading thus minimizing both postoperative pain and hospital stay.

For over than three decades, several thoracic surgeons adopted VATS for anatomical lung resection using two-dimensional (2D) display systems. However, a 2D image lacks depth of perception which may negatively affect surgical manoeuvring.

Three dimensional (3D) display systems for VATS can offer superior magnified vision of the surgical field and better perception of depth during surgical manoeuvring potentially shortening learning curve, which may thus overcome some optical limitations of 2D systems.

In this single center randomized trial our aim is to comparatively assess ergonomics of 3D versus 2D VATS lobectomy for early stage (stage I-II) NSCLC. For this purpose we compared three ergonomical domains: exposure, instrumentation and maneuvering with the aid of a scoring scale entailing analysis of 5 main technical steps: vein, artery bronchus, lymph node and fissure score.

The evaluation process of the five surgical steps was carried out by 4 thoracic surgeons who individually scored all recorded operations.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-04-20
• Study First Posted: 2019-04-23
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
a difference ≥10% in the score calculated for the maneuvring ergonomical domain.	one week after surgery	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.

Secondary Outcome Measures

Name	Time	Method
intraoperative bleeding	intraoperative	Total amount of blood (mL) lost during the surgical procedure
postoperative drainage volume	two weeks after surgery	Total amount of fluid (mL) collected through the chest drain during in-hospital stay
hospital stay	30 days after surgery	Overall duration (days) of in-hospital stay after the surgical procedure
Operative time	during surgery	Total duration (min) of the surgical procedure from first incision opening to last incision closure
surgical mortality	90 days after surgery	Fatal complications occurryng within 90 days after surgery
complications	30 days after surgery	Any adverse event recorded perioperatively or after the surgical procedure during in-hospital stay
a difference ≥10% in the score calculated for the instrumentation ergonomical domain.	one week after surgery	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.
a difference ≥10% in the score calculated for the exposure ergonomical domain.	one week after surgery	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.

Trial Locations

Locations (1)

Policlinico Tor Vergata University; 🇮🇹 Roma, Italy