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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03699878
Enrollment
221
Registered
2018-10-09
Start date
2018-10-12
Completion date
2022-04-18
Last updated
2022-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Robotic Esophagectomy

Brief 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.

Interventions

None listed

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

1. Emergency surgery 2. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.) 3. Chronic kidney disease (eGFR \<30 mL / min / 1.73 m2) 4. Pregnant and lactating women 5. Use of oral anticoagulants

Design outcomes

Primary

MeasureTime frameDescription
base blood concentration of syndecan-1within 1 hour before surgerypreoperative baseline serum levels of syndecan-1
blood concentration of syndecan-1 at the end of the surgerywithin 5 minutes after the end of surgery (when thd surgical drape is removed)blood concentration of syndecan-1 at the end of the surgery
blood concentration of syndecan-1 at 24 hours after surgery24 hours after the end of surgeryblood concentration of syndecan-1 at 24 hours after surgery

Secondary

MeasureTime frameDescription
initial ventilatory support greater than 48 hours (STS GTSD 2.41 #3520)within 30days after end of surgeryIndicate 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.
pneumonia (STS GTSD 2.41 #3460)within 30days after end of surgeryIndicate 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.
Unanticipated Post-Operative Invasive Procedure (STS GTSD 2.41 #3330)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.
mortality(Status 30 Days after Surgery, STS GTSD 2.41 #3950)30days post-surgeryIndicate whether the patient was alive or dead at 30 days post-surgery (whether in the hospital or not). time frame: 30days post-surgery
Acute kidney injurywithin 48 h after end of surgerydefined 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)
renal failure(STS GTSD 2.41 #3810)within 30days after end of surgeryIndicate 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
Anastomotic leak following esophageal surgery(STS GTSD 2.41 #3350)within 30days after end of surgeryIndicate if the patient had an anastomotic leak following esophageal surgery.
Respiratory Failure(STS GTSD 2.41 #3480)within 30days after end of surgeryIndicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026