Association of Preoperative Sarcopenia and Intraoperative Hypotension in Patients Undergoing Minimally Invasive Pylorus Preserving Pancreaticoduodenectomy : Prospective Observational Study

April 20, 2022 updated by: Yonsei University
The aim of this study is to determine whether preoperative sarcopenia (low muscle strength/muscle mass) is correlated with time weighted average intraoperative hypotension in patients undergoing minimally invasive pylorus preserving pancreaticoduodenectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: So Yeon Kim, MD,PhD
  • Phone Number: 82-2-2228-2429
  • Email: KIMSY326@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Health System, Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing minimally invasive pylorus preserving pancreaticoduodenectomy

Description

Inclusion Criteria:

1. patients 20 years or older who undergo minimally invasive pylorus preserving pancreaticoduodenectomy

Exclusion Criteria:

  1. emergency surgery
  2. patients who cannot read consent forms(e.g., illiterate, foreigner, etc.)
  3. patients with cognitive dysfunction
  4. pregnant, lactating women
  5. When hand grip test cannot be performed
  6. patients with atrial fibrillation, moderate or severe valvular heart disease, left ventricular ejection fraction less than 35%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients undergoing minimally invasive pylor-preserving pancreaticoduodenectomy
Adult patients aged 20 years or older and who underg minimally invasive pylor-preserving pancreaticoduodenectomy
Device: Hand grip test, computed tomography
A hand grip test, abdominal computed tomography are performed before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time weighted average intraoperative hypotension
Time Frame: Procedure (From the induction of anesthesia to the end of anesthesia)
1) Intraoperative hypotension is defined as a mean blood pressure < 65 mmHg.
Procedure (From the induction of anesthesia to the end of anesthesia)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: So Yeon Kim, MD,PhD, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 18, 2022

Primary Completion (ANTICIPATED)

March 27, 2024

Study Completion (ANTICIPATED)

March 27, 2024

Study Registration Dates

First Submitted

April 3, 2022

First Submitted That Met QC Criteria

April 8, 2022

First Posted (ACTUAL)

April 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2022-0135

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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