ERAS in Video-assisted Mediastinal Surgery

The Clinical Study of ERAS Protocol in Video-assisted Mediastinal Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Enhanced Recovery After Surgery
• Intervention / Treatment: Combination product: ERAS; Combination product: Traditional measures

Detailed Description

Compare to traditional measures, the ERAS protocal mainly includes:Good preoperative visit, shorten the fast time, minimumal invasive surgery procedures, fewer opioids and early movements after surgery. These items have been successfully used in colon cancer surgery, and we thus plan to investigate the effectiveness of these measures in mediastinal surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital
      • Contact: chao liang, Ph.D; Phone Number: 15921679955; Email: superwm226@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ERAS group; The patients in this group receive enhanced measures perioperatively	Combination product: ERAS; The investigators mainly used enhanced measures perioperatively in mediastinal surgery as these used in other surgery
Active Comparator: Traditional group; The patients in this group receive traditional measures perioperatively	Combination product: Traditional measures; The investigators mainly used traditional measures perioperatively in mediastinal surgery as these used in other surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2017
• Primary Completion (Anticipated): February 23, 2018
• Study Completion (Anticipated): February 23, 2018

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: zs2017822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No