Study to Assess Duration of Indwelling Catheter After Sacrocolpopexy (CARESS)
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|ClinicalTrials.gov Identifier: NCT02189291|
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : March 15, 2019
The objective of this study is to help identify the best practice regarding the use of indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a randomized controlled trial comparing the immediate removal of indwelling urethral catheter, after minimally invasive sacrocolpopexy, to the present standard catheter removal on post operative day one. Evidence based catheter management will be helpful to both providers and patients in post-operative decision making.
Aim 1: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy results in shorter hospital stay than removal on postoperative day 1.
Aim 2: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy confers no increased risk of re-catheterization.
Aim 3: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy decreases the occurrence of urinary tract infection.
A randomized controlled trial comparing the standard overnight indwelling urethral catheterization with removal of catheter immediately post surgery after minimally invasive sacrocolpopexy, at Oregon Health & Science University.
Primary outcome measures are hospital stay in hours after completion of surgery and need for re-catheterization. Hospital stay will be counted from the time the patient leaves the operating room to the time she leaves the hospital. To avoid confounding, investigators are only including the first / morning case of the day. For re-catheterization, investigators will evaluate if patient was able to void after completion of surgery. Investigators will compare the post voiding residuals, the need for re-catheterizations and the numbers of patients going home with an indwelling catheter between the two groups. Investigators will also compare the number of urinary tract infections, as documented by urine culture and subsequent treatment, between the two groups.
Study subjects will be women undergoing minimally invasive sacrocolpopexy. Women will be invited to participate in the study during their preoperative visit. If they agree to participation, this will be noted in their chart. Randomization to group will occur immediately following surgery.
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Organ Prolapse Urinary Tract Infections Urinary Retention||Procedure: Immediate catheter removal Procedure: Post op day 1 catheter removal||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||When to Remove the Indwelling Catheter After Minimally Invasive Sacrocolpopexy?|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||July 1, 2018|
|Actual Study Completion Date :||December 31, 2018|
Experimental: Immediate catheter removal
The indwelling Foley catheter will be removed prior to exiting the operating room.
Procedure: Immediate catheter removal
The indwelling catheter will be removed prior to exiting the operating room.
Active Comparator: Post op day 1 catheter removal
Patients assigned to this group will follow the standard of care at present, with removal of indwelling catheter on the morning of postoperative day 1.
Procedure: Post op day 1 catheter removal
For patients assigned to catheter removal on post operative day one, which is the standard of care at this point.
- Hospital stay [ Time Frame: 4 weeks ]Primary outcome measure is hospital stay in hours after completion of surgery. Hospital stay will be counted from the time the patient leaves the operating room to the time she leaves the hospital.
- Re-catheterization [ Time Frame: Upto 4 weeks ]To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy confers no increased risk of re-catheterization.
- Urinary tract infection [ Time Frame: upto 4 weeks ]To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy decreases the occurrence of urinary tract infection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189291
|United States, Michigan|
|St John Hospital & Medical Center|
|Detroit, Michigan, United States, 48236|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Legacy Good Samaritan Medical Center|
|Portland, Oregon, United States|
|Principal Investigator:||Muhammad F Aslam, MD||St. John Hospital & Medical Center|