Status Approved
First Submitted Date
2020/05/15
Registered Date
2020/05/18
Last Updated Date
2020/10/22
1. Background
CRIS Registration Number |
KCT0005028 |
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Unique Protocol ID | 2020-0761 |
Public/Brief Title | Association of preoperative diaphragm function with postoperative pulmonary complications in patients undergoing robot-assisted laparoscopic prostatectomy |
Scientific Title | Association of preoperative diaphragm function with postoperative pulmonary complications in patients undergoing robot-assisted laparoscopic prostatectomy |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2020-0761 |
Approval Date | 2020-05-15 |
Institutional Review Board Name | Asan Medical Center Institutional Review Board |
Institutional Review Board Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul |
Institutional Review Board Telephone | 02-3010-7166 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Young-Kug Kim |
Title | Professor |
Telephone | +82-2-3010-5976 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea |
Contact Person for Public Queries | |
Name | Jihion Yu |
Title | Clinical instructor |
Telephone | +82-2-3010-3868 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea |
Contact Person for Updating Information | |
Name | Jihion Yu |
Title | Clinical instructor |
Telephone | +82-2-3010-3868 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2020-05-20 Actual | |
Target Number of Participant | 145 | |
Primary Completion Date | 2020-09-19 , Actual | |
Study Completion Date | 2020-09-19 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Asan Medical Center | |
Recruitment Status | Completed | |
Date of First Enrollment | 2020-05-20 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Asan Medical Center |
Organization Type | Medical Institute |
Project ID | 2020-0761 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Asan Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | We will investigate the relationship between preoperative diaphragm function and postoperative pulmonary complications in prostate cancer patients undergoing robotic-assisted laparoscopic prostatectomy. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Cohort |
Time Perspective | Prospective |
Target Number of Participant | 145 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Robotic-assisted laparoscopic prostatectomy group |
Cohort/Group Description The diaphragm thickening fraction is measured using ultrasound before induction of anesthesia in patients undergoing robotic-assisted laparoscopic prostatectomy. |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Prostate cancer patients between 20 and 79 years old who will undergo robotic-assisted laparoscopic prostatectomy |
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Sampling Method | Non-probablity sampling: consequent sampling |
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C61)Malignant neoplasm of prostate Prostatic neoplasms |
Rare Disease | No |
Inclusion Criteria |
Gender Male |
Age 20Year~79Year |
|
Description Prostate cancer patients between 20 and 79 years old who will undergo robotic-assisted laparoscopic prostatectomy American Society of Anesthesiologist Physical Status1 - 3 Paitents who voluntarily consent to participate in this study |
|
Exclusion Criteria |
Patients who refuse to participate in this study Patients who underwent pneumonectomy |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | Incidence of postoperative pulmonary complicaions |
|
Timepoint | During postoperative 7 days |
|
Secondary Outcome(s) 1 | ||
Outcome | Hostpital stay |
|
Timepoint | At discharge day |
|
Secondary Outcome(s) 2 | ||
Outcome | ICU admission rate |
|
Timepoint | During hospitalization |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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