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OpenTrials
Completed

NCT Number: NCT03699878

Impact of Perioperative Shedding of the Endothelial Glycocalyx on Short-term Postoperative Complication in Patients Undergoing Robot-assisted Esophagectomy

The aim of this study was to determine whether changes in serum levels of syndecan-1 before and after surgery, which is an index related to injury of the endothelial glycocalyx layer, are associated with postoperative short-term complications and mortality in patients undergoing robotic esophagectomy.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients 20 years or older who undergo robotic esophagectomy

Exclusion criteria

  • Emergency surgery
  • If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
  • Chronic kidney disease (eGFR <30 mL / min / 1.73 m2)
  • Pregnant and lactating women
  • Use of oral anticoagulants

Treatment and study plan

Primary outcomes

  1. base blood concentration of syndecan-1

    Time frame: within 1 hour before surgery

    preoperative baseline serum levels of syndecan-1

  2. blood concentration of syndecan-1 at the end of the surgery

    Time frame: within 5 minutes after the end of surgery (when thd surgical drape is removed)

    blood concentration of syndecan-1 at the end of the surgery

  3. blood concentration of syndecan-1 at 24 hours after surgery

    Time frame: 24 hours after the end of surgery

    blood concentration of syndecan-1 at 24 hours after surgery

Secondary outcomes

  1. Unanticipated Post-Operative Invasive Procedure (STS GTSD 2.41 #3330)

    Time frame: during this 1 day hospital visit.

    Indicate if the patient had an unplanned invasive procedure after surgery. Examples includes return to the operating room for a redo surgical procedure, a percutaneous procedure performed at bedside or in the radiology suite, a tracheostomy, and wound opening at bedside. Exclusions: postoperative toilet bronchoscopy, central venous access, arterial line placement, foley catheter placement.

  2. Anastomotic leak following esophageal surgery(STS GTSD 2.41 #3350)

    Time frame: within 30days after end of surgery

    Indicate if the patient had an anastomotic leak following esophageal surgery.

  3. Respiratory Failure(STS GTSD 2.41 #3480)

    Time frame: within 30days after end of surgery

    Indicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation.

  4. initial ventilatory support greater than 48 hours (STS GTSD 2.41 #3520)

    Time frame: within 30days after end of surgery

    Indicate if the patient initially was ventilated greater than 48 hours in the postoperative period. If the patient is reintubated, select the postoperative event "Respiratory Failure" and do not select this element even if the reintubation ventilator support is > 48 hours. Ventilator support ends with the removal of the endotracheal tube or if the patient has a tracheostomy tube, until no longer ventilator dependent.

  5. pneumonia (STS GTSD 2.41 #3460)

    Time frame: within 30days after end of surgery

    Indicate if the patient experienced pneumonia in the postoperative period. Pneumonia is defined as meeting three of five characteristics: fever (> 100.4 F or 38 C), leukocytosis, CXR with infiltrate, positive culture from sputum, or treatment with antibiotics.

  6. renal failure(STS GTSD 2.41 #3810)

    Time frame: within 30days after end of surgery

    Indicate whether the patient had acute renal failure or worsening renal function resulting in any of the following:

    • New requirement for dialysis post-operatively
    • Increase in serum creatinine level 3.0 x greater than baseline
    • serum creatinine level ≥4 mg/dL , with an acute rise of at least 0.5 mg/dl
  7. mortality(Status 30 Days after Surgery, STS GTSD 2.41 #3950)

    Time frame: 30days post-surgery

    Indicate whether the patient was alive or dead at 30 days post-surgery (whether in the hospital or not).

    time frame: 30days post-surgery

  8. Acute kidney injury

    Time frame: within 48 h after end of surgery

    defined as an absolute increase in serum creatinine level C0.3 mg/dL, a 50% (1.5-fold) increase in serum creatinine level from baseline, or a reduction in urine output (documented oliguria< 0.5 mL/kg/h for 6h)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2018
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.