Morbidity in Open Versus Minimally Invasive Esophagectomy (MIOMIE)
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|ClinicalTrials.gov Identifier: NCT03035071|
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Procedure: minimally invasive esophagectomy Procedure: open esophagectomy||Not Applicable|
Esophageal resection is still associated with considerable morbidity and mortality. Standardized preoperative efforts could increase the outcome of these patients. While early reports of medical pioneers focused particularly on safety and feasibility, more recent studies showed that implementation of minimally invasive esophagectomy (MIE) was widely accepted. Since first reports of MIE, different techniques and adjustments have been discussed. A recent publication of a large prospective trial in Phase II showed the safety of a total minimally invasive approach (video assisted thoracoscopic surgery (VATS) and laparoscopy). Surgical technique however is still a subject of debate and the level of evidence remains still low. Proving feasibility does not warrant a paradigm shift, as experience is an important factor for safety and patient benefit.
The aim of this study was to evaluate morbidity and mortality of open esophagectomy (OE) versus hybrid-MIE in a randomized controlled setting.
Prior to surgery patients will be randomized either the minimally invasive surgery group (laparoscopic gastric tube formation and thoracotomy) or the the open surgery group (open gastric tube formation with an open laparotomy approach). Randomizing tool is the "randomizer" of the medical university of vienna. (link is attached below)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Morbidity In Open Versus Minimally Invasive Hybrid Esophagectomy|
|Actual Study Start Date :||May 1, 2010|
|Actual Primary Completion Date :||November 19, 2014|
|Actual Study Completion Date :||April 18, 2016|
Experimental: minimally invasive esophagectomy
minimally invasive (laparoscopic) gastric mobilisation and gastric tube formation.
Procedure: minimally invasive esophagectomy
In the MIE group the laparoscopic procedure was performed for gastric tube formation. The patient was placed in supine position with legs apart. The surgeon stands between the legs using a five-trocar technique. Laparoscopy will be followed by an anterolateral thoracotomy in the fourth intercostal space.
Active Comparator: open esophagectomy
open gastric mobilization and gastric tube formation
Procedure: open esophagectomy
in the open group the gastric mobilization and gastric tube formation will be perfumed with an open surgical approach. Laparotomy will be performed, followed by an anterolateral thoracotomy in the fourth intercostal space.
- morbidity [ Time Frame: 30 days ]anastomotic leakage, gastric conduit necrosis and/or pneumonia
- mortality [ Time Frame: 30 days ]
- ICU stay [ Time Frame: 90 days ]length of stay at the intensive care unit (ICU)
- hospital stay [ Time Frame: 90 days ]length of stay at the hospital
- overall survival [ Time Frame: 5 years ]long term overall survival
- relapse free survival [ Time Frame: 5 years ]long term relapse free survival