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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
Sponsor:
Information provided by (Responsible Party):
W. Thomas Gregory, Oregon Health and Science University

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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women undergoing minimally invasive sacrocolpopexy
  • Sacrocolpopexy with or without concomitant procedures
  • Patients having the first start surgery of the day to standardize hospital time.

Exclusion Criteria:

  • Elevated post void residual (PVR)
  • Mobility problems
  • Neurological conditions
  • Intra-operative cystotomy or urinary tract injury

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Muhammad F Aslam, MD St. John Hospital & Medical Center

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Responsible Party: W. Thomas Gregory, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02189291     History of Changes
Other Study ID Numbers: 00010603
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

Keywords provided by W. Thomas Gregory, Oregon Health and Science University:
Indwelling catheter
Hospital stay
Urinary tract infection
Sacrocolpopexy

Additional relevant MeSH terms:
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Prolapse
Urinary Tract Infections
Pelvic Organ Prolapse
Urinary Retention
Pathological Conditions, Anatomical
Infection
Urologic Diseases
Urination Disorders