NCT03699878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

October 12, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2022

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

3.5 years

First QC Date

October 5, 2018

Last Update Submit

November 23, 2022

Conditions

Robotic Esophagectomy

Outcome Measures

Primary Outcomes (3)

  • base blood concentration of syndecan-1

    preoperative baseline serum levels of syndecan-1

    within 1 hour before surgery

  • 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)

  • 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 Outcomes (8)

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

    during this 1 day hospital visit.

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

    within 30days after end of surgery

  • Respiratory Failure(STS GTSD 2.41 #3480)

    within 30days after end of surgery

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

    within 30days after end of surgery

  • pneumonia (STS GTSD 2.41 #3460)

    within 30days after end of surgery

  • +3 more secondary outcomes

Study Arms (1)

patients undergoing robotic esophagectomy

Patients 20 years or older who undergo robotic esophagectomy

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients 20 years or older who undergo robotic esophagectomy

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 03722, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 9, 2018

Study Start

October 12, 2018

Primary Completion

April 18, 2022

Study Completion

April 18, 2022

Last Updated

November 25, 2022

Record last verified: 2022-11

Locations

KR(1)