NCT02910453

Brief Summary

The standard operative approach to pulmonary lesions has been via postero-lateral thoracotomy and direct vision. This technique has some advantages but its morbidity is significant. Some surgeons advocate a resection by video-assisted thoracic surgery (VATS) to reduce the impact on chest wall and the impairment on respiratory mechanic. However, an evidence for superiority of the approach minimally invasive is lacking, particularly for the difficult assessment of the change in pulmonary function. The aim of this study is to compare VATS- over open lobectomy regarding the differences of chest wall kinematic, analyzed by optoelectronic plethysmography (OEP).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
Last Updated

May 7, 2021

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

September 9, 2016

Last Update Submit

May 4, 2021

Conditions

Lung Cancer

Keywords

Pulmonary lobectomyVideo-Assisted Thoracic SurgeryOpto-electronic plethysmographyPosterolateral thoracotomy

Outcome Measures

Primary Outcomes (1)

  • Modification of respiratory kinematic

    Compare VATS- over open pulmonary lobectomy regarding the differences of chest wall kinematic, analyzed by optoelectronic plethysmography (OEP)

    T0: preoperatively (2 weeks before surgery); T1: 1 week after surgery; T2: 2 months after surgery

Study Arms (2)

VATS group

Pulmonary lobectomy via VATS. VATS starts with a utility incision, approximately 4 cm in length, anterior to the latissimus dorsi muscle at the 4th intercostal space. Muscle fibers are split without cutting and a wound protector is regularly placed in site. The camera port is placed in the 6th or 7th intercostal space at the anterior axillary line and a third 10-mm access is made at the same intercostal space at the posterior axillary line. The hilum is approached anteriorly

Procedure: Pulmonary lobectomy

Open group

Pulmonary lobectomy via posterolateral thoracotomy (PLT). PLT consists in a standard 10-15 muscle-sparing incision at 4th intercostal space, rib divaricators are utilized and the hilum is approached posteriorly as previously described

Procedure: Pulmonary lobectomy

Interventions

Pulmonary lobectomyPROCEDURE
Open groupVATS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lung cancer patients suitable for pulmonary lobectomy.

You may qualify if:

  • Lesion not in close relation to the hilar structures (bronchus, vessels) based on CT
  • Non-Small Cell Lung Cancer clinically staged T1-2, N0 or N1, M0
  • Subject must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate a lobectomy

You may not qualify if:

  • Previous thoracic surgery on same side
  • Planned segment resection or pneumonectomy
  • Any type of chronic pain, requiring daily use of analgesics
  • Body Mass Index (BMI) ≥ 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (1)

  • LoMauro A, Aliverti A, Chiesa M, Cattaneo M, Privitera E, Tosi D, Nosotti M, Santambrogio L, Palleschi A. Ribcage kinematics during exercise justifies thoracoscopic versus postero-lateral thoracotomy lobectomy prompt recovery. Eur J Cardiothorac Surg. 2017 Dec 1;52(6):1197-1205. doi: 10.1093/ejcts/ezx174.

    PMID: 28977548DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 22, 2016

Study Start

January 1, 2015

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

May 7, 2021

Record last verified: 2016-09

Locations

IT(1)