Multicentric Study VATS Major Introperative Complications

University Hospital, Gasthuisberg

Status: Completed

Conditions: Lung Neoplasms

Study type: Observational

Funder types: Other

Identifiers

NCT02031809

MC_VATS complic

Details and patient eligibility

About

This study investigates the most common major complications that result in unplanned additional surgery in patients undergoing vats anatomical resections. Several high-volume European centres participate. The purpose is to quantify these major complications, discuss the steps that can be taken to prevent these events, how they can be dealt with, be it by vats or conversion

Full description

Vats lobectomy is becoming the standard of care for early stage lung cancer. Several studies have shown feasibility and safety in dedicated centres. Compared to thoracotomy the procedure results in at least equal oncologic results and survival, perhaps better.

Most series do not publish their early experience. They are retrospective and report on lobectomies and segmentectomies, excluding the live-saving pneumonectomies. They are potentially ignoring the intention-to-treat principle, excluding conversions.

Based on scarce existing literature and conference worst-case presentations a pattern of the most common intraoperative major complications can be drawn In Europe, a large percentage of high-volume-centres have now successfully implemented a vats lobectomy program. In this era with low-volume-centres switching into vats anatomical resections, it is important to focus on potentially life-threatening complications. To be aware of potential hazards is the best way to avoid them.

Enrollment: 3,076 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients that did undergo resection for oncologic reasons

Exclusion criteria

• Patients that did not undergo resection for oncologic reasons, such as pleural metastasis, irresectable disease.

Trial design

3,076 participants in 2 patient groups

No additional unplanned major surgery

Description:

uneventfull intra-operative and postoperative course

Additional unplanned major surgery

Description:

Additional per-operative or post-operative unplanned major surgery such as unforeseen pneumonectomy, bilobectomy, lobectomy or additional segmentectomy, repair of major vessels or bronchi, bronchopleural fistula, unplanned surgery to other organs, within 30 days after the primary surgery. These do not include: * Conversions without additional unplanned major surgery or suddne blood loss less than 500cc * Conversions or additional resection for unforeseen oncologic reasons. * Plasty, repair or sleeve resection of vessels after deliberate resection or transection for oncologic reasons