Urinary Retention After Laparoscopic Inguinal Hernia Repair: Comparing the Use of the Intraoperative Urinary Catheter
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/4/2019 |
| Start Date: | April 15, 2019 |
| End Date: | September 30, 2020 |
| Contact: | Michael Rosen, MD |
| Email: | rosenm@ccf.org |
| Phone: | 216 445-3441 |
Urinary Retention After Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial Comparing Intraoperative Urinary Catheter Versus no Catheter
This will be a randomized controlled study which will compare the rate of post-operative
urinary retention after laparoscopic inguinal hernia repair between patients who receive an
intra-operative urinary catheter and those who do not. The primary aim of the study is to
determine if the use of intra-operative urinary catheter reduces the incidence of
post-operative urinary retention after laparoscopic inguinal hernia repair. Specific patient
inclusion criteria include all patients aged 18 years or older presenting for an elective
unilateral or bilateral inguinal hernia repair, who are able to tolerate general anesthesia
and are considered eligible to have a hernia repair through a laparoscopic approach.
urinary retention after laparoscopic inguinal hernia repair between patients who receive an
intra-operative urinary catheter and those who do not. The primary aim of the study is to
determine if the use of intra-operative urinary catheter reduces the incidence of
post-operative urinary retention after laparoscopic inguinal hernia repair. Specific patient
inclusion criteria include all patients aged 18 years or older presenting for an elective
unilateral or bilateral inguinal hernia repair, who are able to tolerate general anesthesia
and are considered eligible to have a hernia repair through a laparoscopic approach.
An inguinal hernia repair is a common outpatient procedure with a low rate of morbidity. One
well-recognized complication of this operation is post-operative urinary retention (PUR),
which is a failure of spontaneous voiding requiring insertion of a urinary catheter. The
reported incidence of PUR ranges between 0.4 and 3% of open tension-free repairs. For
laparoscopic inguinal hernia repairs that range is between 1 and 22. Since no randomized
controlled trials have evaluated PUR as the primary outcome exist in literature, there is no
consensus on whether catheter use aids in minimizing post-operative urinary retention.
Routine use of intraoperative catheterization increases the risk of urethral trauma,
catheter-associated infections and bladder damage leading to increased cost of care and
potential patient morbidity. On the other hand, PUR is associated with additional procedures,
such as catheterization, which may delay hospital discharge or increase the length of stay
and cause patient discomfort. This work aims to study the effect of intraoperative catheters
on PUR and whether the aforementioned risks associated with this procedure are justified.
We hypothesize that the use of intra-operative urinary catheter reduces the incidence of
postoperative urinary retention after laparoscopic inguinal hernia repair, thus justifying
the potential complications associated with intra-operative catheter insertion.
All patients will be asked to void in the pre-operative area prior to going into the
operating room. Patients will be operated in the supine, and slight Trendelenburg position
(15º degrees), with arms tucked along the body. The procedure will be performed under general
anesthesia. After induction of anesthesia, randomization will occur. It will be performed
according to a computer-generated block randomization scheme. The randomization will be
stratified for unilateral or bilateral hernias. Antibiotic prophylaxis will be performed
according to institutional protocol. Pharmacological prophylaxis of venous thromboembolic
events is usually not necessary for general laparoscopic inguinal hernia repair. Although, if
deemed necessary, this will be performed per Surgical Care Improvement Project (SCIP)
protocol and will not be considered a protocol deviation. Skin preparation and hair removal
will be performed per SCIP protocol. All necessary materials, including the urine
catheterization kit, will be available in the operative room before the start of the
procedure.
The Americas Hernia Society Quality Collaborative (AHSQC) registry will serve as the main
platform for data collection. Registry-based trials use data available in a preexisting
database to increase the efficiency of performing RCTs, decreasing the high cost and
logistical challenges associated with operationalizing this type of research. Post-operative
urinary retention will be defined as post-operative failure to void requiring straight
catheterization, placement of an indwelling catheter or return to the emergency department
due to failure to void after discharge from the hospital. Bladder scanning, its timing and
specific criteria for placement of urinary catheter will be determined by the standard
policies of each institution where the surgery was performed and the surgeon.
Specific Aim #1: To determine if the use of intra-operative urinary catheter reduces the
incidence of postoperative urinary retention after laparoscopic inguinal hernia repair. This
will be assessed by comparing the PUR rates between the two study groups.
Specific Aim #2: To determine if there is a difference in the rates of intraoperative bladder
injuries between the study groups. This will be determined by comparing the rates of
intraoperative bladder injuries between the two study groups.
Specific Aim #3: To determine the rate of urinary tract complications after insertion of the
intra operative urinary catheter for the control group. This will be accomplished by
analyzing the rates of urinary tract injury, infections and bladder injuries due to
intraoperative catheter placement.
Specific Aim #4: To determine the rate of urinary tract complications after insertion of a
urinary catheter for patients who develop PUR. This will be accomplished by analyzing the
rates of urinary tract injury, or infections and bladder injuries due to catheter placement
after patients develop PUR.
well-recognized complication of this operation is post-operative urinary retention (PUR),
which is a failure of spontaneous voiding requiring insertion of a urinary catheter. The
reported incidence of PUR ranges between 0.4 and 3% of open tension-free repairs. For
laparoscopic inguinal hernia repairs that range is between 1 and 22. Since no randomized
controlled trials have evaluated PUR as the primary outcome exist in literature, there is no
consensus on whether catheter use aids in minimizing post-operative urinary retention.
Routine use of intraoperative catheterization increases the risk of urethral trauma,
catheter-associated infections and bladder damage leading to increased cost of care and
potential patient morbidity. On the other hand, PUR is associated with additional procedures,
such as catheterization, which may delay hospital discharge or increase the length of stay
and cause patient discomfort. This work aims to study the effect of intraoperative catheters
on PUR and whether the aforementioned risks associated with this procedure are justified.
We hypothesize that the use of intra-operative urinary catheter reduces the incidence of
postoperative urinary retention after laparoscopic inguinal hernia repair, thus justifying
the potential complications associated with intra-operative catheter insertion.
All patients will be asked to void in the pre-operative area prior to going into the
operating room. Patients will be operated in the supine, and slight Trendelenburg position
(15º degrees), with arms tucked along the body. The procedure will be performed under general
anesthesia. After induction of anesthesia, randomization will occur. It will be performed
according to a computer-generated block randomization scheme. The randomization will be
stratified for unilateral or bilateral hernias. Antibiotic prophylaxis will be performed
according to institutional protocol. Pharmacological prophylaxis of venous thromboembolic
events is usually not necessary for general laparoscopic inguinal hernia repair. Although, if
deemed necessary, this will be performed per Surgical Care Improvement Project (SCIP)
protocol and will not be considered a protocol deviation. Skin preparation and hair removal
will be performed per SCIP protocol. All necessary materials, including the urine
catheterization kit, will be available in the operative room before the start of the
procedure.
The Americas Hernia Society Quality Collaborative (AHSQC) registry will serve as the main
platform for data collection. Registry-based trials use data available in a preexisting
database to increase the efficiency of performing RCTs, decreasing the high cost and
logistical challenges associated with operationalizing this type of research. Post-operative
urinary retention will be defined as post-operative failure to void requiring straight
catheterization, placement of an indwelling catheter or return to the emergency department
due to failure to void after discharge from the hospital. Bladder scanning, its timing and
specific criteria for placement of urinary catheter will be determined by the standard
policies of each institution where the surgery was performed and the surgeon.
Specific Aim #1: To determine if the use of intra-operative urinary catheter reduces the
incidence of postoperative urinary retention after laparoscopic inguinal hernia repair. This
will be assessed by comparing the PUR rates between the two study groups.
Specific Aim #2: To determine if there is a difference in the rates of intraoperative bladder
injuries between the study groups. This will be determined by comparing the rates of
intraoperative bladder injuries between the two study groups.
Specific Aim #3: To determine the rate of urinary tract complications after insertion of the
intra operative urinary catheter for the control group. This will be accomplished by
analyzing the rates of urinary tract injury, infections and bladder injuries due to
intraoperative catheter placement.
Specific Aim #4: To determine the rate of urinary tract complications after insertion of a
urinary catheter for patients who develop PUR. This will be accomplished by analyzing the
rates of urinary tract injury, or infections and bladder injuries due to catheter placement
after patients develop PUR.
Inclusion Criteria:
- 18 years of age or older
- Able to give informed consent
- Unilateral or bilateral inguinal hernia
- Scheduled for elective inguinal hernia repair
- Eligible to tolerate general anesthesia
- Eligible to undergo minimally invasive inguinal hernia repair
Exclusion Criteria:
- Diagnosed with benign prostate hyperplasia (BPH)
- Younger than 18 years old
- Unable to give informed consent
- Emergent inguinal hernia repairs ( acute incarceration or strangulation)
- Unable to tolerate general anesthesia
- Not eligible for minimally invasive inguinal hernia repair
We found this trial at
1
site
Click here to add this to my saved trials
