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Status unknownNCT03271606Updated Sep 5, 2017

ERAS in Video-assisted Mediastinal Surgery

A Phase 1 interventional study of ERAS and Traditional measures in Enhanced Recovery After Surgery, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-09-05.

Sponsored by Shanghai Zhongshan Hospital · Phase 1, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Enhanced Recovery After Surgery
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient refuse;
  • ASA≥3;
  • Patients allergic to used anesthetics (propofol,rocuronium), patients with liver and/or kidney and/or mental dysfunction.
04

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    ERAS group

    The patients in this group receive enhanced measures perioperatively

    Combination Product: ERAS

  • Active comparator
    Traditional group

    The patients in this group receive traditional measures perioperatively

    Combination Product: Traditional measures

Interventions

  • Combination productERAS

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

  • Combination productTraditional measures

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

05

What researchers measure

Primary outcomes

  1. 15-item quality of recovery scale (QoR-15)

    This scale mainly reflects the patient's status

    Time frame: At preoperative vist

  2. 15-item quality of recovery scale (QoR-15)

    This scale mainly reflects the patient's status

    Time frame: At 24 hours after surgery

06

Study locations

1 of 1 sites recruiting
  • Zhongshan Hospital
    Shanghai, Shanghai 200032, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03271606
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
Sep 5, 2017
Start date
Aug 23, 2017
Primary completion
Feb 23, 2018 (estimated)
Completion
Feb 23, 2018 (estimated)
Last update
Sep 5, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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