Ignite Creation Date:
2024-05-06 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03633994
Status:
UNKNOWN
Last Update Posted:
2019-10-10
First Post:
2018-08-13
Brief Title:
Heparin Intraoperative Instillation for Lower Urinary Tract Symptoms After Benign Hysterectomy
Sponsor:
The Christ Hospital
Organization:
The Christ Hospital
Study Overview
Official Title:
Heparin Intraoperative Instillation for Lower Urinary Tract Symptoms After Benign Hysterectomy A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HILUTS
Brief Summary:
This study will explore the application of placing heparin into the bladder via a catheter to decrease postoperative lower urinary tract symptoms LUTS and urinary tract infection UTI symptoms such as urinary frequency urinary urgency pain with urination or difficulty voiding following hysterectomy surgically removing the uterus The investigators hypothesize that heparin bladder instillations will reduce LUTS UTI symptoms and improve patient satisfaction following hysterectomy
Detailed Description:
Data Collection
Subject demographics and history information will be obtained from The Christ Hospital Medical Centers electronic medical record In addition preoperative diagnosis postoperative diagnosis procedure performed total operative time estimated blood loss intraoperative complications anterior prolapse repair use of cystoscopy preoperative urinalysis postoperative complications uterine size and any urine cultures collected within the 2 week postoperative period will also obtained from the electronic medical record
The post-operative lower urinary tract symptoms assessments will be collected the paper records will be secured in a locker labeled with the study identification number which will then be entered into EXCEL on a password secured database and the paper copy will be disposed of in the secure destruction station
Descriptive Analysis
Simple statistics and demographics will be done across the two cohorts Categorical variables will be analyzed using Chi-square while continuous variables eg UTISA scores will be analyzed using t-test so long as the distribution of the data are normal Additional analyzes as appropriate will be done to identify group differences based on patient demographics eg age concomitant procedures surgeon estrogen use foley catheter placement etc
Data Analysis and Data Monitoring
The UTISA survey and VAS pain scale both result a continuous variable that between the two cohorts will be compared using a t-Test provided the results distribution is normal Antibiotic use or self-reported UTI rates are nominal variables that across the cohorts would be compared using a X2
Data analysis will be performed using statistical software JMP 1320 SAS Institute Inc Cary NC USA The data will be assembled into a password protected EXCEL Microsoft Redmond WA USA spreadsheet A separate password protected spreadsheet will link the study ID and the enrolled patients MRN Analysis would be done only on the de-identified data
Data Storage and Confidentiality
Study data will be managed in a password-protected EXCEL Microsoft Redmond WA USA spreadsheet on a password-protected computer A separate password protected spreadsheet linking the study ID and MRN will be kept on a separate password-protected secure drive This key file will be securely destroyed when the data has been fully analyzed Paper records including consent will be in a locked research drawer in the designated locked office The investigators will dispose of any paper documents after data has been analyzed using the CINTAS Secure Destruction Station
Sample Size
The symptom with the highest sensitivity and specificity to predict a UTI is dysuria A study in 2013 demonstrated a 50 reduction in UTIs among heparin treated patients the investigators estimated an effect size of 06 assuming mean UTISA dysuria scores of 2 and 1 among the untreated and treated cohorts assessed on post-operative day 1 Assuming an α of 005 and 80 power the investigators estimate requiring 45 subjects per study arm totaling 90 patients Assuming at least 15 attrition in each arm the investigators estimate needing to enroll at least 52 patients per study arm to a total of 104 patients
Plans for recruitment of subjects
No advertisement will be used The recruitment will take at the time of surgical consent via phone after patient is identified at the time of preoperative visit or on the day of surgery
Subject demographics and history information will be obtained from The Christ Hospital Medical Centers electronic medical record In addition preoperative diagnosis postoperative diagnosis procedure performed total operative time estimated blood loss intraoperative complications anterior prolapse repair use of cystoscopy preoperative urinalysis postoperative complications uterine size and any urine cultures collected within the 2 week postoperative period will also obtained from the electronic medical record
The post-operative lower urinary tract symptoms assessments will be collected the paper records will be secured in a locker labeled with the study identification number which will then be entered into EXCEL on a password secured database and the paper copy will be disposed of in the secure destruction station
Descriptive Analysis
Simple statistics and demographics will be done across the two cohorts Categorical variables will be analyzed using Chi-square while continuous variables eg UTISA scores will be analyzed using t-test so long as the distribution of the data are normal Additional analyzes as appropriate will be done to identify group differences based on patient demographics eg age concomitant procedures surgeon estrogen use foley catheter placement etc
Data Analysis and Data Monitoring
The UTISA survey and VAS pain scale both result a continuous variable that between the two cohorts will be compared using a t-Test provided the results distribution is normal Antibiotic use or self-reported UTI rates are nominal variables that across the cohorts would be compared using a X2
Data analysis will be performed using statistical software JMP 1320 SAS Institute Inc Cary NC USA The data will be assembled into a password protected EXCEL Microsoft Redmond WA USA spreadsheet A separate password protected spreadsheet will link the study ID and the enrolled patients MRN Analysis would be done only on the de-identified data
Data Storage and Confidentiality
Study data will be managed in a password-protected EXCEL Microsoft Redmond WA USA spreadsheet on a password-protected computer A separate password protected spreadsheet linking the study ID and MRN will be kept on a separate password-protected secure drive This key file will be securely destroyed when the data has been fully analyzed Paper records including consent will be in a locked research drawer in the designated locked office The investigators will dispose of any paper documents after data has been analyzed using the CINTAS Secure Destruction Station
Sample Size
The symptom with the highest sensitivity and specificity to predict a UTI is dysuria A study in 2013 demonstrated a 50 reduction in UTIs among heparin treated patients the investigators estimated an effect size of 06 assuming mean UTISA dysuria scores of 2 and 1 among the untreated and treated cohorts assessed on post-operative day 1 Assuming an α of 005 and 80 power the investigators estimate requiring 45 subjects per study arm totaling 90 patients Assuming at least 15 attrition in each arm the investigators estimate needing to enroll at least 52 patients per study arm to a total of 104 patients
Plans for recruitment of subjects
No advertisement will be used The recruitment will take at the time of surgical consent via phone after patient is identified at the time of preoperative visit or on the day of surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None