VATS Versus Open Pulmonary Lobectomy in the Limelight of OEP

NCT ID: NCT02910453

Last Updated: 2021-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

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).

Detailed Description

Rationale: 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 and its relation with chest wall modifications.

Objective: The aim of this study is to compare VATS- over open lobectomy regarding the differences of chest wall kinematic analyzed by optoelectronic plethysmography (OEP).

Study design: A prospective mono-centre single blind trial. Study population: Adult patients of either gender candidate for pulmonary lobectomy for non small cell lung cancer.

Intervention: Patients are submitted to pulmonary lobectomy by video-assisted technique or by postero-lateral thoracotomy. This decision follows the usual clinical evaluations, regardless of whether or not the study enrollment. In particular, they are candidates for postero-lateral thoracotomy if: tumors were close to the hilum or other relevant anatomical structures, or the computed tomography demonstrated hilar calcific lymph-nodes or the lesions were of greater than 4 cm diameter.

Endpoint is evaluation of modification of respiratory kinematic after pulmonary lobectomy, assessed by OEP. In particular, the volume variation of pulmonary rib cage of the treated side versus the relative untreated side and the differences. Respiratory movements and thoracic and abdominal volume changes will be recorded continuously by analyzing the movements of retro-reflective markers using 8 video-cameras connected to an automatic optoelectronic motion analyzer. Subjects are prepared for OEP (markers). Baseline spirometry is take prior to exercise test. All exercise take place on an electromagnetically braked cycle-ergometer. Throughout the protocol heart rate, oxygen saturation and dyspnoea with the Borg scale are recorded. Ventilatory kinematics are monitored throughout exercise using OEP. This OEP analysis involves compartmentalization of the chest into three sections: pulmonary rib cage, abdominal rib cage, and abdomen to determine the contribution of each component to total chest wall volume.

Conditions

Lung Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Pulmonary lobectomy

Intervention Type: PROCEDURE

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

Pulmonary lobectomy

Intervention Type: PROCEDURE

Interventions

Pulmonary lobectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Politecnico di Milano

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 28977548 (View on PubMed)

Other Identifiers

VOLO-2016-2583

Identifier Type: -

Identifier Source: org_study_id