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

Robotic Esophagectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699878
• Other study ID #: 4-2018-0773
• Status: Completed
• Start date: October 12, 2018
• Est. completion date: April 18, 2022

Study information

• Verified date: November 2022
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: April 18, 2022
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications
• Robotic Esophagectomy

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	base blood concentration of syndecan-1	preoperative baseline serum levels of syndecan-1	within 1 hour before surgery
Primary	blood concentration of syndecan-1 at the end of the surgery	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)
Primary	blood concentration of syndecan-1 at 24 hours after surgery	blood concentration of syndecan-1 at 24 hours after surgery	24 hours after the end of surgery
Secondary	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.	during this 1 day hospital visit.
Secondary	Anastomotic leak following esophageal surgery(STS GTSD 2.41 #3350)	Indicate if the patient had an anastomotic leak following esophageal surgery.	within 30days after end of surgery
Secondary	Respiratory Failure(STS GTSD 2.41 #3480)	Indicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation.	within 30days after end of surgery
Secondary	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.	within 30days after end of surgery
Secondary	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.	within 30days after end of surgery
Secondary	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: 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	within 30days after end of surgery
Secondary	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	30days post-surgery
Secondary	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)	within 48 h after end of surgery