Trial document




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  DRKS00009513

Trial Description

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Title

'Enhanced recovery after surgery' (ERAS) following Ivor-Lewis esophagectomy

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Trial Acronym

ERAS after Ivor-Lewis esophagectomy

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URL of the Trial

http://Keine

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Brief Summary in Lay Language

For patients with esophageal carcinoma the resection of the esophagus (Ivor-Lewis esophagectomy) is considered to be the standard treatment. However, this operative procedure is associated with a considerable complication rate as well as mortality. The major goal of scientific investigations is to reduce the complication rate and therefore increase the patient’s safety. One possible option is the so called ‚enhanced recovery after surgery‘ protocol (ERAS) which aims to accelerate patient’s recovery after the operation. This program requires a close collaboration between the surgical and anaesthesiological staff members before, during and after the operation. The protocol include the improvement of lung function before the operation, the early extubation in the operating theatre, the early mobilization at the day of the operation as well as the early enteral feeding commencing the day after the operation. In this study, 40 patients without significant other co-morbidities and scheduled for this operation will be included. This patient group will be compared to a control group without the ERAS protocol. The study wants to prove that the ERAS protocol will reduce the rate of major complications but also to shorten the hospital stay by 2-5 days.

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Brief Summary in Scientific Language

Ivor-Lewis esophagectomy for esophageal cancer is still associated with a considerable postoperative morbidity and mortality. In order to improve postoperative outcome a standardized clinical pathway liniking perioperative anaesthetic and surgical management is necessary. ‘Enhanced recovery after surgery’ (ERAS) is a multidisciplinary protocol offering an innovative concept of perioperative medical care for high-risk surgical patients. Data regarding esophageal cancer surgery are limited and the effect of ERAS protocols in Ivor-Lewis esophagectomy remains controversial.
This study aims to implement an ERAS program for a selective group of patients with esophageal carcinoma scheduled for Ivor-Lewis esophagectomy. The collaborative program involves anaesthetic and surgical staff members of the operating theatre, ICU and ward. Early involvement of professional physiotherapeutic activity in the ERAS program is essential.
Compared to the standard perioperative management the ERAS protocol intends to fasten postoperative recovery. This includes major changes of the preoperative assessment and pulmonary training, perioperative analgesia, intraoperative monitoring, ventilator and fluid management, early extubation, postoperative mobilization, respiratory training and oral feeding. As a major goal of ERAS patients are intended to be discharged from hospital 2-5 days earlier compared to patients with standard care.
This prospective study will be performed in a high-volume center and Center of Excellence for Surgery of the Upper GI with a yearly case load > 150 esophagectomies. The study group will consist of 40 patients scheduled for Ivor-Lewis esophagectomy. Eligibility criteria of patients primarily include the preoperative functional resectability. The statistical methodology is based on a propensity score matching. The study group will be compared with a historical control group of 80 patients who had Ivor-Lewis esophagectomy in 2013/2014. It is hypothesized that ERAS patients have a lower rate of major complications classified as Dindo-Clavien III - V (primary outcome variable) and therefore will be able to be discharged earlier without limitations in the quality of care. Secondary outcome variable is the hospital stay (in days) and the associated overall costs. The acquisition of the sample size is expected to take 12-18 months.

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Organizational Data

  •   DRKS00009513
  •   2015/12/04
  •   [---]*
  •   yes
  •   Pending/not yet approved
  •   15-409, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Esophageal carcinoma
  •   C15 -  Malignant neoplasm of oesophagus
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Interventions/Observational Groups

  •   Patiens with ERAS program (early extubation, early mobilisation at the operation day, enteral feeding at POD 1, endoscopie at POD 5, discharge before POD 12)
  •   patients withour ERAS program
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Supportive care
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Rate of postoperative IIIB and IV complication (Clavien-Dindo score)

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Secondary Outcome

Hospital stay (in days) and hospital costs (in Euro)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/01/04
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Patients with esophageal carcinoma with/without neoadjuvant therapy scheduled for Ivor-Lewis esophagectomy
• ASA I and II
• Preoperative weight loss < 10% of body weight
• BMI >18.5 and <30
• Respiratory function: FEV and VC >80%,
• Cardiovascular function: Stress ECG > 100 Watt, no history of MI
• Informed consent

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Exclusion Criteria

• Chronic renal failure
• Insulin dependent diabetes mellitus

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Addresses

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    • Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Universitätsklinikum Köln
    • Mr.  Porf. Dr.  Wolfgang  Schröder 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Universitätsklinikum Köln
    • Mr.  Prof. Dr.  Wolfgang  Schröder 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.