Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02189291 |
| Other study ID # |
00010603 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2014 |
| Est. completion date |
December 31, 2018 |
Study information
| Verified date |
March 2019 |
| Source |
Oregon Health and Science University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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
Placement of indwelling catheter after minimally invasive pelvic organ prolapse (POP) surgery
is routine practice. There is limited evidence to support the use of overnight indwelling
catheters, and despite this, the use of catheters after urogynecologic surgery remains common
practice. The objective of this study is to help identify the best practice regarding the use
of indwelling catheter after minimally invasive urogynecologic surgery. Dunn et al found that
immediate removal of catheter after completion of an uncomplicated abdominal or vaginal
hysterectomy was not associated with re-catheterization, urinary tract infections or fever.
They also found that patients in whom the catheter was removed immediately had less pain
compared to the patients who had indwelling catheter for 24 hours. The applicability of this
study to Urogynecology is limited by the fact that patients with incontinence and / or
prolapse were not included in it. Use of catheters after surgery may be convenient for
providers, but the benefit to the patient is uncertain. Investigators believe that evidence
with regards to the optimal use of catheter use in urogynecologic surgery will be helpful to
the providers.
Risk of urinary tract infection increases the longer an indwelling catheter stays in a
patient. Urinary tract infections associated with catheters (CAUTI) are responsible for 40%
of hospital acquired infections. CAUTI are associated with 387, 550 hospital acquired
infections in a year, which could be prevented. Investigators believe that avoiding placement
of catheter after minimally invasive urogynecologic surgery will result in shorter hospital
stay and reduction in CAUTI, thereby improving the quality and cost of health care.
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.
Background
Most patients stay in hospital for a 23-hour observation following minimally invasive
urogynecologic surgery. The usual practice is to leave the indwelling urethral catheter
overnight after these procedures. The use of indwelling catheters after surgery is carried
for multiple reasons, including measuring urinary output and prevention of urinary retention
after surgery. The use of indwelling Foley catheter after surgery is associated with
prolonged hospital stay, fever and urinary tract infection. A study by Haakvort et al
compared removal of indwelling catheter on post operative day 1 to longer catheterization
after vaginal and found a tenfold reduction in urinary tract infections.
The removal of indwelling catheter may affect the length of stay in hospital, with associated
budgetary and economic implications. One study found that removal of indwelling catheter at
midnight results in patients being discharged 0.7 days earlier than patients who had their
catheters removed in the morning. This results in shorter length of hospital stay and
improved discharge planning. There is a wide variation in practice and policies regarding
catheter removal. With no clear evidence-based practice regarding catheter removal, and lack
of data in literature with regards to catheter removal after urogynecologic surgery,
practices vary among physicians and institutions. Audits in British hospitals found that
almost half of the catheters were removed either at the discretion of the nurse or at the
time of rounds in the morning. Another study found that when the catheters were scheduled to
be removed in the morning, only 70% were removed in time.
Dunn et al looked into removal of indwelling catheter immediately after hysterectomy compared
to removal after 24 hours. They found that immediate removal of catheter after surgery was
not associated with any adverse outcomes or need for re-catheterization, and patients with
immediate removal reported significantly less pain compared to their counterparts who had
catheter removal at 24 hours. Similarly, Alessandri found that women who had their catheter
removed early had a shorter mean ambulation time and their hospital stay was shorter by 19
hours. This shows the economic benefit with early discharge associated with early catheter
removal, however such a study is lacking in urogynecology literature.
In addition to potential benefits to health care costs, immediate catheter removal has
several health benefits. There is evidence that early ambulation reduces the incidence of
clinically evident deep venous thrombosis. Therefore, early removal of indwelling urethral
catheter after surgery may contribute towards reducing postoperative morbidity by reducing
the incidence of post operative deep venous thrombosis and decrease health care cost by
aiding towards early discharge. Another advantage of immediate catheter removal after surgery
is lower incidence of urinary tract infection.
There are few studies offering insight into postoperative voiding efficiency after
uncomplicated minimally invasive urogynecologic surgery. There is variation in practice with
regards to the length of time the indwelling catheter is left in place. Multiple factors
contribute to how long a catheter stays. In the absence of strong evidence, this decision
depends on physician preference, staff convenience and patient tolerance. The use of
indwelling urethral catheter is the usual practice after gynecologic and POP surgery. Despite
this routine practice, there seems to be little evidence supporting the use of indwelling
urethral catheter after gynecologic surgery. Generally, the indwelling urethral catheter is
used after surgery for monitoring output, or if the patient is not mobile. This may not be
the usual case after urogynecologic surgery. Some of the reasons for routine use of catheter
after urogynecologic surgery include allowing bladder emptying as voiding may be difficult
due to the effects of the surgery, such as pain or swelling of surrounding soft tissues. The
routine use of indwelling catheters after routine urogynecologic surgery carries the risk of
morbidity including detrusor overactivity, urinary tract infection or pain in urethra.
There is a lack of agreement among providers regarding the optimal time for removal of
urethral catheter after surgery. Usual practices are based on provider preference and the
already established institution practices rather than evidence based practice. Although
different institutions and providers have different practices and policies, there is no
evidence based practice regarding the effect of the time when catheter is removed or for the
length of time catheter is left in place prior to removal after surgery. Most places will
leave the catheter overnight after surgery. One possible reason for that may be that the
reduced staff at night may not respond to the complication of urinary retention, following
catheter removal. Another perceived reason for leaving the catheter in overnight is that
patients will rest through the night and then get back to their normal voiding the next day,
once the catheter is removed in the morning. Cochrane review by Griffiths and Fernandez had
suggested the need for randomized trials to address questions regarding catheter removal
among discrete subgroups and specialties. The usual practice of indwelling foley catheter
after urogynecologic surgery may be convenience to the providers, but there is limited
evidence in literature regarding what benefits patients gain from this practice.
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.
Data Collection
Investigators will obtain demographic information. On post operative day 1, investigators
will obtain patient satisfaction and pain scores. Pain score will be obtained with the use of
pictorial "Wong Scale," assessing level of pain and location (i.e., bladder or urethra vs.
the surgical site). Furthermore, patients will be asked whether they will use the same
treatment again (yes or no).
All patients are to expect discharge the following day and counseled as such. Patients
assigned to immediate removal will undergo the following protocol: The indwelling catheter
will be removed prior to exiting the operating room. If the patient has an urge to void
immediately post operatively, the void will be recorded and post void residual determined by
bladder scan. If the post void residual is no more than 1/3 of the total volume, the patient
will be considered to have passed the voiding trial and have no further intervention. In
patients with more than 1/3 post void residual or inability to void four hours after
completion of surgery, bladder volume will be checked with a bladder scan. In subjects with
less than 300 mL of urine, they will be given an additional two hours to void. For patients
with >300 mL of urine, they will undergo straight catheterization and re-enter the voiding
trial cycle. For patients who have not voided at six hours, straight catheterization will be
performed and they will re-enter the voiding trial cycle and given four hours to void. This
process will continue for three total cycles (1st cycle post operative, two cycles
thereafter), at which time they will be given an indwelling catheter.
For patients assigned to catheter removal on post operative day one, investigators will
perform backfill voiding trial prior to catheter removal. Investigators are planning to
perform backfill voiding trial as it has not been shown to be inferior to waiting to void and
this will avoid confounding regarding the discharge time from hospital. Bladder will be
filled with 300 mL of sterile water and the indwelling catheter will then be removed. Patient
will be asked to void in a hat thereafter, if they are able to void at least 200 mL, they
would have completed a successful voiding trial. If they are unable to void, then
investigators will perform straight catheterization and allow them four hours to void.
Patients unable to pass the voiding trial after two attempts will go home with either an
indwelling catheter or performing self catheterization (depending on patient's comfort). For
the purpose of the study, patients going home with a catheter or self catheterization will be
in the same group of going home with a catheter. Investigators will compare the incidence of
urinary tract infections within four weeks after surgery, as documented by urine culture and
/ or treatment.
