NCT04615494

Brief Summary

The purpose of this study is to evaluate the change of the internal carotid artery blood flow according to the steep trendelenburg position and pneumoperitoneum in patients undergoing robot-assisted laparoscopic prostatectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

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

First Submitted

Initial submission to the registry

November 3, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

November 17, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

November 3, 2020

Last Update Submit

January 25, 2021

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Difference in internal carotid artery blood flow

    Difference between the internal carotid artery blood flow measured at 10 minutes after anesthetic induction during supine position and the internal carotid artery blood flow measured at 10 minutes after pneumoperitoneum with steep Trendelenburg position

    At 10 minutes after pneumoperitoneum with steep Trendelenburg position

Secondary Outcomes (5)

  • Internal carotid artery blood flow

    Baseline (Before anesthetic induction)

  • Internal carotid artery blood flow

    At 10 minutes after anesthetic induction

  • Internal carotid artery blood flow

    At 10 minutes after pneumoperitoneum and Trendelenburg position

  • Internal carotid artery blood flow

    At 30 minutes after pneumoperitoneum and Trendelenburg position

  • Internal carotid artery blood flow

    Procedure (At skin closure)

Interventions

PositionPROCEDURE

Pneumoperitoneum with Steep Trendelenburg position

Eligibility Criteria

Age20 Years - 79 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have undergone robot-assisted laparoscopic prostatectomy with prostate cancer

You may qualify if:

  • Patients who have undergone robot-assisted laparoscopic prostatectomy with prostate cancer and who are 20 years or older and under 80 years
  • Patients who agree to voluntarily participate in this study
  • Patients with ASA class 1-2

You may not qualify if:

  • History of diagnosis of cerebrovascular disease
  • Patients who refused to participate in clinical studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Young-Kug Kim, Professor

    Asan Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 4, 2020

Study Start

November 17, 2020

Primary Completion

January 21, 2021

Study Completion

January 22, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

KR(1)