NCT03271606

Brief Summary

This is a single center, randomized,single blind study to investigate the effectiveness of enhanced recovery regimen (ERAS) in patients undergoing Video-assisted Mediastinal Surgery. And we also going to compare the effectiveness of ERAS with that of traditional regimen in these patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

August 23, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 23, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2018

Completed
Last Updated

September 5, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

August 23, 2017

Last Update Submit

September 1, 2017

Conditions

Enhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (2)

  • 15-item quality of recovery scale (QoR-15)

    This scale mainly reflects the patient's status

    At preoperative vist

  • 15-item quality of recovery scale (QoR-15)

    This scale mainly reflects the patient's status

    At 24 hours after surgery

Study Arms (2)

ERAS group

EXPERIMENTAL

The patients in this group receive enhanced measures perioperatively

Combination Product: ERAS

Traditional group

ACTIVE COMPARATOR

The patients in this group receive traditional measures perioperatively

Combination Product: Traditional measures

Interventions

ERASCOMBINATION_PRODUCT

The investigators mainly used enhanced measures perioperatively in mediastinal surgery as these used in other surgery

ERAS group
Traditional measuresCOMBINATION_PRODUCT

The investigators mainly used traditional measures perioperatively in mediastinal surgery as these used in other surgery

Traditional group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients elective mediastinal surgery;
  • BMI 18-30 kg/m2.

You may not qualify if:

  • Patient refuse;
  • ASA≥3;
  • Patients allergic to used anesthetics (propofol,rocuronium), patients with liver and/or kidney and/or mental dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

September 5, 2017

Study Start

August 23, 2017

Primary Completion

February 23, 2018

Study Completion

February 23, 2018

Last Updated

September 5, 2017

Record last verified: 2017-09

Locations

CN(1)