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POsitioning for Esophageal Cancer Resection (POETRI)

Primary Purpose

Esophageal Cancer

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Repositioning
Single positioning
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed, non-metastatic esophagus cancer (squamous or adenocarcinoma) or AEG I tumors requiring curative thoracoabdominal esophagectomy with intrathoracic anastomosis of a gastric tube immediately after diagnosis or after neoadjuvant treatment
  • 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 established indication for colon interposition or cervical anastomosis
  • 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)

Sites / Locations

  • Department of Surgery, University Hospital Dresden

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Repositioning Group

Single positioning

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

operating time
Operating time is defined from the start of patient positioning until final closing and dressing of all wounds.

Secondary Outcome Measures

Full Information

First Posted
May 12, 2014
Last Updated
October 19, 2017
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT02157363
Brief Title
POsitioning for Esophageal Cancer Resection
Acronym
POETRI
Official Title
POsitioning for Esophageal Cancer Resection - a Randomized Controlled TRIal (POETRI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment due to change of surgical technique
Study Start Date
June 16, 2014 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Open thoracoabdominal esophagectomy (TAE) is the standard curative treatment modality for resectable esophageal cancer. TAE can be achieved by positioning the patient in the supine position for the abdominal part and in a left-lateral decubitus (LLD) position for the thoracic part, or by performing both parts in a left-screwed supine position (LSS). Aim of the present study is to compare peri- and postoperative outcome variables after TAE for esophageal cancer in the two positions. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repositioning Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Single positioning
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Repositioning
Intervention Type
Procedure
Intervention Name(s)
Single positioning
Primary Outcome Measure Information:
Title
operating time
Description
Operating time is defined from the start of patient positioning until final closing and dressing of all wounds.
Time Frame
The endpoint is assessed at the end of the operation (finishing of all wound dressings) on the day of operation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed, non-metastatic esophagus cancer (squamous or adenocarcinoma) or AEG I tumors requiring curative thoracoabdominal esophagectomy with intrathoracic anastomosis of a gastric tube immediately after diagnosis or after neoadjuvant treatment 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 established indication for colon interposition or cervical anastomosis 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thilo Welsch, MD
Organizational Affiliation
Department of Surgery, University Hospital Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, University Hospital Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

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POsitioning for Esophageal Cancer Resection

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