Study to Assess Duration of Indwelling Catheter After Sacrocolpopexy
CARESS
When to Remove the Indwelling Catheter After Minimally Invasive Sacrocolpopexy?
1 other identifier
interventional
72
1 country
3
Brief Summary
Objectives 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. Specific Aims 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. Design 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. Outcome measures 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2014
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 3, 2014
CompletedFirst Posted
Study publicly available on registry
July 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedMarch 15, 2019
March 1, 2019
4 years
July 3, 2014
March 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital stay
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.
4 weeks
Secondary Outcomes (2)
Re-catheterization
Upto 4 weeks
Urinary tract infection
upto 4 weeks
Study Arms (2)
Immediate catheter removal
EXPERIMENTALThe indwelling Foley catheter will be removed prior to exiting the operating room.
Post op day 1 catheter removal
ACTIVE COMPARATORPatients assigned to this group will follow the standard of care at present, with removal of indwelling catheter on the morning of postoperative day 1.
Interventions
The indwelling catheter will be removed prior to exiting the operating room.
For patients assigned to catheter removal on post operative day one, which is the standard of care at this point.
Eligibility Criteria
You may qualify if:
- Women undergoing minimally invasive sacrocolpopexy
- Sacrocolpopexy with or without concomitant procedures
- Patients having the first start surgery of the day to standardize hospital time.
You may not qualify if:
- Elevated post void residual (PVR)
- Mobility problems
- Neurological conditions
- Intra-operative cystotomy or urinary tract injury
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
St John Hospital & Medical Center
Detroit, Michigan, 48236, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Legacy Good Samaritan Medical Center
Portland, Oregon, United States
Related Publications (2)
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
PMID: 34184246DERIVEDAslam MF, Bazzi AA, Hagglund KH, Osmundsen BC. When to Remove the Indwelling Catheter After Minimally Invasive Sacrocolpopexy? CARESS (CAtheter REmoval after Sacrocolpopexy Surgery). Female Pelvic Med Reconstr Surg. 2020 Feb;26(2):120-127. doi: 10.1097/SPV.0000000000000826.
PMID: 31990800DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammad F Aslam, MD
St. John Hospital & Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 3, 2014
First Posted
July 14, 2014
Study Start
July 1, 2014
Primary Completion
July 1, 2018
Study Completion
December 31, 2018
Last Updated
March 15, 2019
Record last verified: 2019-03