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

NCT03835351 | Completed Results FDA Device

• 1 other identifier: 19-070
• Study Type: interventional
• Target: 491
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Keywords

Urinary catheter; Urinary retention; Laparoscopic inguinal hernia repair

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Post Operative Urinary Retention

  The rate of postoperative urinary retention requiring insertion of a urinary catheter

  From the day of surgery until postoperative day 30

Secondary Outcomes (3)

• Number of Participants With Intraoperative Bladder Injuries

  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

  From the day of surgery until postoperative day 30

• Number of Participants With Complications Urinary Catheter Who Develop Retention

  From the day of surgery until postoperative day 30

Study Arms (2)

Intraoperative urinary catheter

OTHER

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

NO INTERVENTION

No intraoperative urinary catheter will be used during the case

Interventions

Urinary Catheter DEVICE

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

Also known as: Foley

Intraoperative urinary catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Comprehensive Hernia Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (9)

• 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.

  PMID: 16490551 BACKGROUND

• 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.

  PMID: 12430114 BACKGROUND

• 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.

  PMID: 28871414 BACKGROUND

• 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.

  PMID: 25552230 BACKGROUND

• 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.

  PMID: 24200291 BACKGROUND

• 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.

  PMID: 27316825 BACKGROUND

• 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.

  PMID: 30449696 BACKGROUND

• 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.

  PMID: 38710888 DERIVED

• 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.

  PMID: 35704302 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal; Urinary Retention

Interventions

Urinary Catheters; Urinary Catheterization

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies; Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Dr. Michael Rosen
• Organization: Cleveland Clinic Foundation

rosenm@ccf.org

12164453441

Study Officials

• Michael Rosen, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Comprehensive Hernia Center

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 8, 2019
• Study Start: March 7, 2019
• Primary Completion: March 24, 2021
• Study Completion: April 15, 2021
• Last Updated: May 3, 2022
• Results First Posted: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)