Urinary Retention After Laparoscopic Inguinal Hernia Repair: Comparing the Use of the Intraoperative Urinary Catheter

Not Applicable

Completed

Conditions: Inguinal Hernia

Interventions: Device: Urinary Catheter

Registration Number: NCT03835351

Lead Sponsor: The Cleveland Clinic

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 491

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraoperative urinary catheter	Urinary Catheter	After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Post Operative Urinary Retention	From the day of surgery until postoperative day 30	The rate of postoperative urinary retention requiring insertion of a urinary catheter

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Intraoperative Bladder Injuries	Measured from Beginning of Anesthesia to the End of Anesthesia and up to 4 hours Post Operatively	This will be determined by comparing the rates of intraoperative bladder injuries between the two study groups
Number of Participants Who Have Complications From Intra-operative Urinary Catheter	From the day of surgery until postoperative day 30	This will be accomplished by analyzing the rates of urinary tract injury, infections and bladder injuries due to intraoperative catheter placement.
Number of Participants With Complications Urinary Catheter Who Develop Retention	From the day of surgery until postoperative day 30	This will be accomplished by analyzing the rates of urinary tract injury, or infections and bladder injuries due to catheter placement after patients develop post operative urinary retention.