Morbidity in Open Versus Minimally Invasive Esophagectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-01

Study Completion Date

2016-04-18

Brief Summary

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The MIOMIE trial is a prospective randomized controlled study comparing open and laparoscopic gastric tube formation in Ivor Lewis esophagectomy. Aim of this trial was to compare the minimally invasive approach with the standard open procedure regarding morbidity and mortality.

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Detailed Description

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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)

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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minimally invasive esophagectomy

minimally invasive (laparoscopic) gastric mobilisation and gastric tube formation.

Group Type EXPERIMENTAL

minimally invasive esophagectomy

Intervention Type PROCEDURE

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.

open esophagectomy

open gastric mobilization and gastric tube formation

Group Type ACTIVE_COMPARATOR

open esophagectomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adenocarcinoma of the esophagus and the esophagogastric junction in (Siewert) type I and II position
* esophageal squamous cell cancer
* patients, who require esophageal resection due to above mentioned diagnosis
* patients, who gave their informed consent

* patients with tumor localization in the upper third of the esophagus and requiring cervical resection were excluded.
* patients, presenting other than AC or ESCC or showed contraindication for laparoscopy (history of large abdominal surgery or signs of hostile abdomen)
* patients with a history or presence of any other malignancy, except carcinoma in situ or basalioma

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No