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

NCT ID: NCT03835351

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 491 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-07
• Study Completion Date: 2021-04-15

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.

Conditions

Inguinal Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Urinary Catheter

Intervention Type: DEVICE

An intraoperative urinary catheter will be inserted which will be taken out at the end of the case

No intraoperative urinary catheter

No intraoperative urinary catheter will be used during the case

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Urinary Catheter

An intraoperative urinary catheter will be inserted which will be taken out at the end of the case

Intervention Type: DEVICE

Other Intervention Names

Foley

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Michael Rosen

Director of the Comprehensive Hernia Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Comprehensive Hernia Center

Cleveland, Ohio, United States

Countries

United States

References

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. doi: 10.1016/j.amjsurg.2005.10.042.

Reference Type: BACKGROUND

PMID: 16490551 (View on PubMed)

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. doi: 10.1053/rapm.2002.37122.

Reference Type: BACKGROUND

PMID: 12430114 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28871414 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25552230 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24200291 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27316825 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30449696 (View on PubMed)

Woo KP, Ellis RC, Maskal SM, Remulla D, Shukla P, Rosen AJ, Wetzka I, Osei-Koomson W, Phillips S, Miller BT, Beffa LR, Petro CC, Krpata DM, Prabhu AS, Menzo EL, Rosen MJ. The association of permanent versus absorbable fixation on developing chronic post-herniorrhaphy groin pain in patients undergoing laparoscopic inguinal hernia repair. Surg Endosc. 2024 Jun;38(6):3433-3440. doi: 10.1007/s00464-024-10866-z. Epub 2024 May 6.

Reference Type: DERIVED

PMID: 38710888 (View on PubMed)

Fafaj A, Lo Menzo E, Alaedeen D, Petro CC, Rosenblatt S, Szomstein S, Massier C, Prabhu AS, Krpata DM, Cha W, Montelione K, Tastaldi L, Alkhatib H, Zolin SJ, Okida LF, Rosen MJ. Effect of Intraoperative Urinary Catheter Use on Postoperative Urinary Retention After Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2022 Aug 1;157(8):667-674. doi: 10.1001/jamasurg.2022.2205.

Reference Type: DERIVED

PMID: 35704302 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

19-070

Identifier Type: -

Identifier Source: org_study_id