NCT03619759

Brief Summary

This study is retrospective study. The purpose of this study is checking the effect of sugammadex on the outcome after colorectal surgery. The outcome is compared among the 2 groups, sugammadex group and non-sugammadex group. The primary parameters of outcome are length of stay, readmission rate, postoperative complications, time interval for first successful oral intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
585

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 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

Study Start

First participant enrolled

March 22, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

July 10, 2018

Last Update Submit

August 18, 2019

Conditions

Keywords

SugammadexColorectal surgerypostoperative complication

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    Length of stay in hospital

    admission to discharge (within 1 month)

Secondary Outcomes (3)

  • Readmission rate

    30 days after discharge

  • postoperative complication rate

    after colorectal surgery, within 30 days

  • Time to first successful oral intake

    within 30 days

Study Arms (2)

Sugammadex

Patients who used sugammadex Sugammadex 1 vial (200mg) intravenous, at the end surgery, before extubation

Drug: Sugammadex

Non-sugammadex

Patients who didn't use sugammadex Pyridostigmine 15\~20mg intravenous, at the end of surgery, before extubation

Interventions

Sugammadex injection as a reverse agent of neuromuscular blocking

Also known as: Bridion
Sugammadex

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 21 and 80 years old, who took the colorectal surgery due to colorectal cancer from Jan, 2012 to Dec, 2017

You may qualify if:

  • Subjects aged 21\~80
  • Subjects who took colorectal surgery due to colon or rectal cancer from Jan, 2012 to Dec, 2017

You may not qualify if:

  • Emergency surgery
  • Paraplegia or quadriplegia
  • Bedridden state d/t various reason
  • Neuromuscular disease
  • Combined operation wth other surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou university school of medicine

Suwon, Gyeonggi-do, 16377, South Korea

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Officials

  • In Kyong Yi, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

July 10, 2018

First Posted

August 8, 2018

Study Start

March 22, 2018

Primary Completion

August 31, 2018

Study Completion

September 1, 2018

Last Updated

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

No sharing

Locations