Overview

This trial is active, not recruiting.

Condition lung neoplasms
Sponsor University Hospital, Gasthuisberg
Start date January 2014
End date December 2016
Trial size 2000 participants
Trial identifier NCT02031809, MC_VATS complic

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
uneventfull intra-operative and postoperative course
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

Primary Outcomes

Measure
additional unplanned major surgery
time frame: during vats anatomical resection or at revision within 30 days

Secondary Outcomes

Measure
number of conversions to open surgery
time frame: during VATS procedure

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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.

Additional Information

Official title Analysis of the Most Common Major Intraoperative Complications During Video-assisted Thoracoscopic Surgery (VATS) Anatomical Resections - On Behalf of MITIG-ESTS
Principal investigator Herbert Dacaluwé, MD
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 Most series do not publish their early experience.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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University Hospital, Gasthuisberg.