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

Completed

• Conditions: Robotic Esophagectomy

• Registration Number: NCT03699878
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-09
• Study Start: 2018-10-12
• Primary Completion: 2022-04-18
• Study Completion: 2022-04-18
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-23
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 221

Inclusion Criteria

1. patients 20 years or older who undergo robotic esophagectomy

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
blood concentration of syndecan-1 at 24 hours after surgery	24 hours after the end of surgery	blood concentration of syndecan-1 at 24 hours after surgery
base blood concentration of syndecan-1	within 1 hour before surgery	preoperative baseline serum levels of syndecan-1
blood concentration of syndecan-1 at the end of the surgery	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

Secondary Outcome Measures

Name	Time	Method
pneumonia (STS GTSD 2.41 #3460)	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.
renal failure(STS GTSD 2.41 #3810)	within 30days after end of surgery	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
initial ventilatory support greater than 48 hours (STS GTSD 2.41 #3520)	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.
mortality(Status 30 Days after Surgery, STS GTSD 2.41 #3950)	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
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.
Anastomotic leak following esophageal surgery(STS GTSD 2.41 #3350)	within 30days after end of surgery	Indicate if the patient had an anastomotic leak following esophageal surgery.
Respiratory Failure(STS GTSD 2.41 #3480)	within 30days after end of surgery	Indicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation.
Acute kidney injury	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)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of