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

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03835351
• Collaborator: (none)
• Enrollment: 491
• Location: 1
• Arms: 2
• Actual Duration (Months): 25.3
• Patients Per Site Per Month: 19.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inguinal Hernia	Device: Urinary Catheter	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 491 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Urinary Retention After Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial Comparing Intraoperative Urinary Catheter Versus no Catheter
• Actual Study Start Date: Mar 7, 2019
• Actual Primary Completion Date: Mar 24, 2021
• Actual Study Completion Date: Apr 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Intraoperative 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.	Device: Urinary Catheter; An intraoperative urinary catheter will be inserted which will be taken out at the end of the case; Other Names: Foley
No Intervention: No intraoperative urinary catheter No intraoperative urinary catheter will be used during the case

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Comprehensive Hernia Center	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Michael Rosen, MD, The Cleveland Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 21, 2019
• Informed Consent Form - Jan 25, 2021

More Information

Publications

• Arnold MR, Coakley KM, Fromke EJ, Groene SA, Prasad T, Colavita PD, Augenstein VA, Kercher KW, Heniford BT. Long-term assessment of surgical and quality-of-life outcomes between lightweight and standard (heavyweight) three-dimensional contoured mesh in laparoscopic inguinal hernia repair. Surgery. 2019 Apr;165(4):820-824. doi: 10.1016/j.surg.2018.10.016. Epub 2018 Nov 16.
• Blair AB, Dwarakanath A, Mehta A, Liang H, Hui X, Wyman C, Ouanes JPP, Nguyen HT. Postoperative urinary retention after inguinal hernia repair: a single institution experience. Hernia. 2017 Dec;21(6):895-900. doi: 10.1007/s10029-017-1661-4. Epub 2017 Sep 4.
• Jensen P, Mikkelsen T, Kehlet H. Postherniorrhaphy urinary retention--effect of local, regional, and general anesthesia: a review. Reg Anesth Pain Med. 2002 Nov-Dec;27(6):612-7. Review.
• Koch CA, Grinberg GG, Farley DR. Incidence and risk factors for urinary retention after endoscopic hernia repair. Am J Surg. 2006 Mar;191(3):381-5.
• Muysoms FE, Vanlander A, Ceulemans R, Kyle-Leinhase I, Michiels M, Jacobs I, Pletinckx P, Berrevoet F. A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh according to the European Registry for Abdominal Wall Hernias Quality of Life Instrument. Surgery. 2016 Nov;160(5):1344-1357. doi: 10.1016/j.surg.2016.04.026. Epub 2016 Jun 14.
• Patel JA, Kaufman AS, Howard RS, Rodriguez CJ, Jessie EM. Risk factors for urinary retention after laparoscopic inguinal hernia repairs. Surg Endosc. 2015 Nov;29(11):3140-5. doi: 10.1007/s00464-014-4039-z. Epub 2015 Jan 1.
• Sivasankaran MV, Pham T, Divino CM. Incidence and risk factors for urinary retention following laparoscopic inguinal hernia repair. Am J Surg. 2014 Feb;207(2):288-92. doi: 10.1016/j.amjsurg.2013.06.005. Epub 2013 Nov 5.

• Responsible Party: Michael Rosen, Director of the Comprehensive Hernia Center, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03835351
• Other Study ID Numbers: 19-070
• First Posted: Feb 8, 2019
• Last Update Posted: May 3, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Michael Rosen, Director of the Comprehensive Hernia Center, The Cleveland Clinic: Urinary catheter; Urinary retention; Laparoscopic inguinal hernia repair
• Additional relevant MeSH terms: Urinary Retention; Hernia; Hernia, Inguinal

Study Results

Participant Flow

Arm/Group Title	Intraoperative Urinary Catheter	No Intraoperative Urinary Catheter
Arm/Group Description	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. Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case	No intraoperative urinary catheter will be used during the case
Period Title: Overall Study
STARTED	241	250
COMPLETED	241	250
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intraoperative Urinary Catheter	No Intraoperative Urinary Catheter	Total
Arm/Group Description	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. Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case	No intraoperative urinary catheter will be used during the case	Total of all reporting groups
Overall Participants	241	250	491
Age (Years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Years]	61	62	61
Sex: Female, Male (Count of Participants)
Female	9 3.7%	17 6.8%	26 5.3%
Male	232 96.3%	233 93.2%	465 94.7%
Race/Ethnicity, Customized (Count of Participants)
Asian or Pacific Islander	4 1.7%	3 1.2%	7 1.4%
Black, not of Hispanic Origin	18 7.5%	33 13.2%	51 10.4%
Hispanic	5 2.1%	9 3.6%	14 2.9%
Middle Eastern	5 2.1%	1 0.4%	6 1.2%
White, not of Hispanic Origin	209 86.7%	204 81.6%	413 84.1%
Region of Enrollment (participants) [Number]
United States	241 100%	250 100%	491 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intraoperative Urinary Catheter	No Intraoperative Urinary Catheter
Arm/Group Description	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. Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case	No intraoperative urinary catheter will be used during the case
Measure Participants	241	250
Count of Participants [Participants]	23 9.5%	21 8.4%

2. Secondary Outcome

Title	Number of Participants With Intraoperative Bladder Injuries
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intraoperative Urinary Catheter	No Intraoperative Urinary Catheter
Arm/Group Description	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. Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case	No intraoperative urinary catheter will be used during the case
Measure Participants	241	250
Count of Participants [Participants]	0 0%	0 0%

3. Secondary Outcome

Title	Number of Participants Who Have Complications From Intra-operative Urinary Catheter
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intraoperative Urinary Catheter	No Intraoperative Urinary Catheter
Arm/Group Description	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. Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case	No intraoperative urinary catheter will be used during the case
Measure Participants	241	250
Intraop Complication Urethral Trauma	1 0.4%	0 0%
Intraop Complication, other	5 2.1%	1 0.4%

4. Secondary Outcome

Title	Number of Participants With Complications Urinary Catheter Who Develop Retention
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intraoperative Urinary Catheter	No Intraoperative Urinary Catheter
Arm/Group Description	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. Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case	No intraoperative urinary catheter will be used during the case
Measure Participants	241	250
Urinary Tract Injury	1 0.4%	0 0%
Bladder Injuries	0 0%	0 0%
Infection	21 8.7%	28 11.2%
None	219 90.9%	222 88.8%

Adverse Events

Time Frame	30 days following surgery
Arm/Group Title	Intraoperative Urinary Catheter		No Intraoperative Urinary Catheter
Arm/Group Description	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. Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case		No intraoperative urinary catheter will be used during the case
All Cause Mortality
	Intraoperative Urinary Catheter		No Intraoperative Urinary Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/241 (0%)		0/250 (0%)
Serious Adverse Events
	Intraoperative Urinary Catheter		No Intraoperative Urinary Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/241 (0.4%)		0/250 (0%)
Renal and urinary disorders
Urethra Injury	1/241 (0.4%)	1	0/250 (0%)	0
Other (Not Including Serious) Adverse Events
	Intraoperative Urinary Catheter		No Intraoperative Urinary Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/241 (1.2%)		11/250 (4.4%)
Blood and lymphatic system disorders
Anemia Requiring Transfusion	1/241 (0.4%)	1	0/250 (0%)	0
Gastrointestinal disorders
Ileus	0/241 (0%)	0	1/250 (0.4%)	1
Bowel Obstruction	0/241 (0%)	0	2/250 (0.8%)	2
Infections and infestations
Urinary Tract Infection	2/241 (0.8%)	2	6/250 (2.4%)	6
Renal and urinary disorders
Renal Failure	0/241 (0%)	0	1/250 (0.4%)	1
Vascular disorders
Deep Vein Thrombosis	0/241 (0%)	0	1/250 (0.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.