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

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03699878

Collaborator

(none)

200

Enrollment

Location

48.6

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Robotic Esophagectomy

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 14, 2018

Anticipated Primary Completion Date :

Oct 3, 2022

Anticipated Study Completion Date :

Oct 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
patients undergoing robotic esophagectomy Patients 20 years or older who undergo robotic esophagectomy

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
initial ventilatory support greater than 48 hours (STS GTSD 2.41 #3520) [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.
pneumonia (STS GTSD 2.41 #3460) [within 30days after end of surgery]
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: 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
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
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT03699878

Other Study ID Numbers:

4-2018-0773

First Posted:

Oct 9, 2018

Last Update Posted:

May 25, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Postoperative Complications

Study Results

No Results Posted as of May 25, 2021