N/A
N=491
Urinary Retention After Laparoscopic Inguinal Hernia Repair: Comparing the Use of the Intraoperative Urinary Catheter
Inguinal Hernia
Bottom Line
View on ClinicalTrials.gov: NCT03835351 ↗Enrolled (actual)
491
Serious AEs
0.2%
Results posted
May 2022
Primary outcome: Primary: Number of Participants With Post Operative Urinary Retention — 23; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Urinary Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Post Operative Urinary Retention |
23; 21 | — |
| SECONDARY Number of Participants With Intraoperative Bladder Injuries |
0; 0 | — |
| SECONDARY Number of Participants Who Have Complications From Intra-operative Urinary Catheter |
1; 0; 5; 1 | — |
| SECONDARY Number of Participants With Complications Urinary Catheter Who Develop Retention |
1; 0; 0; 0; 21; 28 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03835351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.