Study Results
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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TERMINATED
NA
47 participants
INTERVENTIONAL
2014-06-16
2017-02-28
Brief Summary
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POETRI is designed as a single-center, randomized controlled trial with two parallel arms including patients with resectable esophageal cancer and type I cancers of the esophagogastric junction (AEG I). Exclusion criteria are inability to tolerate surgery or both types of positioning, inability to perform an intrathoracic anastomosis, non-malignant pathologies. The primary endpoint is operating time. Secondary endpoints are morbidity, lymph node yield, pulmonary function, pain control and wound healing assessed during a follow-up of 3 months.
POETRI is a single-center, randomized controlled trial to evaluate different positioning and thoracic access during radical open thoracoabdominal esophagectomy for patients with resectable esophageal cancer.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Repositioning Group
The patient is placed on a vacuum mattress in supine position for the abdominal part using a midline laparotomy. After completion of the abdominal part, the abdomen is closed and dressed in standard fashion and the patient is repositioned under full anesthesia is a left-lateral decubitus (LLD) position. After the thorax is sterile prepped and draped, a right dorso-lateral thoracotomy in the 4th to 6th intercostal space under preservation of body of the serratus muscle is performed.
Repositioning
Single positioning
The patient is placed on a vacuum mattress and in a left-screwed supine position for the entire operative procedure. The pelvis and the lower extremities are placed at 0° rotation, whereas the torso is rotated leftwards to an angle of 45° (Fig. 1). The patient is prepped and draped from the shoulders to the inguinal region. A midline laparotomy is done for the abdominal part and the abdomen closed afterwards. For the thoracic part, the operating table is tilted about 30° to the left, and a right anterolateral thoracotomy is performed in the 4th to 6th intercostal space.
Single positioning
Interventions
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Repositioning
Single positioning
Eligibility Criteria
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Inclusion Criteria
* Patients are considered fit for surgery by a local interdisciplinary team of surgeons, medical oncologists and anesthesiologists (ECOG performance status of 0,1, or 2).
* Age ≥ 18 years
* Written informed consent
Exclusion Criteria
* Preoperative diagnosed tracheo-esophageal fistula
* History of right thoracotomy or prior lung surgery
* Physical inability of the described intraoperative patient positioning
* Non-malignant esophageal pathology or other malignancies except squamous or adenocarcinoma
* Planned laparoscopic or thoracoscopic surgical approach
* Patients not eligible for TAE (ASA ≥ 4)
18 Years
ALL
No
Sponsors
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Technische Universität Dresden
OTHER
Responsible Party
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Principal Investigators
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Thilo Welsch, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, University Hospital Dresden
Locations
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Department of Surgery, University Hospital Dresden
Dresden, , Germany
Countries
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Other Identifiers
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TW-001
Identifier Type: -
Identifier Source: org_study_id