An interventional study of Urinary Catheter in Inguinal Hernia, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
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.
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.
561 studies on the registry are indexed under Hernia, Inguinal; 76 are open to participants now.
This study's enrollment of 491 is above the median of 90 across 414 interventional studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: Urinary Catheter
No intraoperative urinary catheter will be used during the case
An intraoperative urinary catheter will be inserted which will be taken out at the end of the case
Also known as: Foley
Number of Participants With Post Operative Urinary Retention
The rate of postoperative urinary retention requiring insertion of a urinary catheter
Time frame: From the day of surgery until postoperative day 30
Number of Participants With Intraoperative Bladder Injuries
This will be determined by comparing the rates of intraoperative bladder injuries between the two study groups
Time frame: Measured from Beginning of Anesthesia to the End of Anesthesia and up to 4 hours Post Operatively
Number of Participants Who Have Complications From Intra-operative Urinary Catheter
This will be accomplished by analyzing the rates of urinary tract injury, infections and bladder injuries due to intraoperative catheter placement.
Time frame: From the day of surgery until postoperative day 30
Number of Participants With Complications Urinary Catheter Who Develop Retention
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.
Time frame: From the day of surgery until postoperative day 30
| Milestone | Intraoperative Urinary Catheter | No Intraoperative Urinary Catheter |
|---|---|---|
| Started | 241 | 250 |
| Completed | 241 | 250 |
| Not completed | 0 | 0 |
The rate of postoperative urinary retention requiring insertion of a urinary catheter
| Participants | Intraoperative Urinary Catheter | No Intraoperative Urinary Catheter |
|---|---|---|
| Number of Participants With Post Operative Urinary Retention | 23 | 21 |
This will be determined by comparing the rates of intraoperative bladder injuries between the two study groups
| Participants | Intraoperative Urinary Catheter | No Intraoperative Urinary Catheter |
|---|---|---|
| Number of Participants With Intraoperative Bladder Injuries | 0 | 0 |
This will be accomplished by analyzing the rates of urinary tract injury, infections and bladder injuries due to intraoperative catheter placement.
| participants | Intraoperative Urinary Catheter | No Intraoperative Urinary Catheter |
|---|---|---|
| Intraop Complication Urethral Trauma | 1 | 0 |
| Intraop Complication, other | 5 | 1 |
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.
| Participants | Intraoperative Urinary Catheter | No Intraoperative Urinary Catheter |
|---|---|---|
| Urinary Tract Injury | 1 | 0 |
| Bladder Injuries | 0 | 0 |
| Infection | 21 | 28 |
| None | 219 | 222 |
Collected over 30 days following surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intraoperative Urinary Catheter | 0/241 (0%) | 1/241 (0.4%) | 3/241 (1.2%) |
| No Intraoperative Urinary Catheter | 0/250 (0%) | 0/250 (0%) | 11/250 (4.4%) |
| Event | Intraoperative Urinary Catheter | No Intraoperative Urinary Catheter |
|---|---|---|
| Urethra InjuryRenal and urinary disorders | 1/241 | 0/250 |
| Event | Intraoperative Urinary Catheter | No Intraoperative Urinary Catheter |
|---|---|---|
| Urinary Tract InfectionInfections and infestations | 2/241 | 6/250 |
| Bowel ObstructionGastrointestinal disorders | 0/241 | 2/250 |
| Anemia Requiring TransfusionBlood and lymphatic system disorders | 1/241 | 0/250 |
| IleusGastrointestinal disorders | 0/241 | 1/250 |
| Deep Vein ThrombosisVascular disorders | 0/241 | 1/250 |
| Renal FailureRenal and urinary disorders | 0/241 | 1/250 |
| Age, Continuous(Years) | Intraoperative Urinary Catheter | No Intraoperative Urinary Catheter | Total |
|---|---|---|---|
| Median | 61 (52 to 68) | 62 (49 to 69) | 61 (51 to 68) |
| Sex: Female, Male(Participants) | Intraoperative Urinary Catheter | No Intraoperative Urinary Catheter | Total |
|---|---|---|---|
| Female | 9 | 17 | 26 |
| Male | 232 | 233 | 465 |
| Race/Ethnicity, Customized(Participants) | Intraoperative Urinary Catheter | No Intraoperative Urinary Catheter | Total |
|---|---|---|---|
| Asian or Pacific Islander | 4 | 3 | 7 |
| Black, not of Hispanic Origin | 18 | 33 | 51 |
| Hispanic | 5 | 9 | 14 |
| Middle Eastern | 5 | 1 | 6 |
| White, not of Hispanic Origin | 209 | 204 | 413 |
| Region of Enrollment(participants) | Intraoperative Urinary Catheter | No Intraoperative Urinary Catheter | Total |
|---|---|---|---|
| United States | 241 | 250 | 491 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual participant data will not be shared, rather the results of the aggregate groups of patients will be shared
Ran from Mar 2019 to primary completion in Mar 2021, 24 months.
Results were first posted in May 2022, 1 year 1 month after primary completion.
Of 181 non-industry interventional studies with no phase under Hernia, Inguinal, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's 24 months is above that.
Counting every sponsor, half of 190 studies reached it within 17 months; a quarter within 8 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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