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Robotic EsophagectomyNCT03699878

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

An observational study of Robotic Esophagectomy, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Robotic Esophagectomy
How many people
221 participants
Where
1 siteSouth Korea
Study dates
12 Oct 2018to 18 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: patients 20 years or older who undergo robotic esophagectomy

Who may be able to join

  • 1. patients 20 years or older who undergo robotic esophagectomy

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

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

    Seoul, 03722

Other trials in South Korea

About this study

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03699878
Study groupRoleWhat they receive
patients undergoing robotic esophagectomyPatients 20 years or older who undergo robotic esophagectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. base blood concentration of syndecan-1

    preoperative baseline serum levels of syndecan-1

    Measured: within 1 hour before surgery

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

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

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

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

    blood concentration of syndecan-1 at 24 hours after surgery

    Measured: 24 hours after the end of surgery

Secondary outcomes (8)

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

    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.

    Measured: during this 1 day hospital visit.

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

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

    Measured: within 30days after end of surgery

  3. Respiratory Failure(STS GTSD 2.41 #3480)

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

    Measured: within 30days after end of surgery

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

    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.

    Measured: within 30days after end of surgery

  5. pneumonia (STS GTSD 2.41 #3460)

    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.

    Measured: within 30days after end of surgery

  6. renal failure(STS GTSD 2.41 #3810)

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

    1. New requirement for dialysis post-operatively
    2. Increase in serum creatinine level 3.0 x greater than baseline
    3. serum creatinine level ≥4 mg/dL , with an acute rise of at least 0.5 mg/dl

    Measured: within 30days after end of surgery

  7. mortality(Status 30 Days after Surgery, STS GTSD 2.41 #3950)

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

    time frame: 30days post-surgery

    Measured: 30days post-surgery

  8. Acute kidney injury

    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)

    Measured: within 48 h after end of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2018
  2. Study start12 Oct 2018
  3. Primary completion18 Apr 2022
  4. Study completion18 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03699878
Sponsor's protocol ID
4-2018-0773
Status last verified
Nov 2022
First submitted
5 Oct 2018
Last updated
25 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Robotic Esophagectomy, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

base blood concentration of syndecan-1 (time frame: within 1 hour before surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03699878.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.

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