NCT03835351

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

Completed NA Results posted Last updated 3 May 2022

What this trial tests

NA trial testing Urinary Catheter in Inguinal Hernia in 491 participants. Completed in 15 April 2021.

Timeline

7 March 2019

Primary endpoint
24 March 2021

15 April 2021

Quick facts

Lead sponsor	The Cleveland Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	491
Start date	7 March 2019
Primary completion	24 March 2021
Estimated completion	15 April 2021
Sites	1 location across United States

Drugs / interventions tested

• Urinary Catheter

Conditions studied

• Inguinal Hernia — all drugs for Inguinal Hernia →

Sponsor

The Cleveland Clinic

Who can join

18 and older, any sex, with Inguinal Hernia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Post Operative Urinary Retention Primary · From the day of surgery until postoperative day 30

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

Group	Value	95% CI
Intraoperative Urinary Catheter	23
No Intraoperative Urinary Catheter	21

Number of Participants With Intraoperative Bladder Injuries Secondary · 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

Group	Value	95% CI
Intraoperative Urinary Catheter	0
No Intraoperative Urinary Catheter	0

Number of Participants Who Have Complications From Intra-operative Urinary Catheter Secondary · 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.

Intraop Complication Urethral Trauma

Group	Value	95% CI
Intraoperative Urinary Catheter	1
No Intraoperative Urinary Catheter	0

Intraop Complication, other

Group	Value	95% CI
Intraoperative Urinary Catheter	5
No Intraoperative Urinary Catheter	1

Number of Participants With Complications Urinary Catheter Who Develop Retention Secondary · 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.

Group	Value	95% CI
Intraoperative Urinary Catheter	1
No Intraoperative Urinary Catheter	0
Intraoperative Urinary Catheter	0
No Intraoperative Urinary Catheter	0
Intraoperative Urinary Catheter	21
No Intraoperative Urinary Catheter	28
Intraoperative Urinary Catheter	219
No Intraoperative Urinary Catheter	222

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days following surgery. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intraoperative Urinary Catheter

Serious: 1/241 (0%)

Deaths: 0/241

No Intraoperative Urinary Catheter

Serious: 0/250 (0%)

Deaths: 0/250

Serious adverse events (1 terms)

Reaction	System	Intraoperative Urinary Cat…	No Intraoperative Urinary …
Urethra Injury	Renal and urinary disorders	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Intraoperative Urinary Cat…	No Intraoperative Urinary …
Urinary Tract Infection	Infections and infestations	—	—
Bowel Obstruction	Gastrointestinal disorders	—	—
Anemia Requiring Transfusion	Blood and lymphatic system disorders	—	—
Ileus	Gastrointestinal disorders	—	—
Deep Vein Thrombosis	Vascular disorders	—	—
Renal Failure	Renal and urinary disorders	—	—

Most-reported serious reactions: Urethra Injury.

Data from ClinicalTrials.gov NCT03835351 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Strategies for the removal of short-term indwelling urethral catheters in adults.
   Ellahi A, Stewart F, Kidd EA, Griffiths R, et al · · 2021 · cited 18× · PMID 34184246 · DOI 10.1002/14651858.cd004011.pub4
2. Effect of Intraoperative Urinary Catheter Use on Postoperative Urinary Retention After Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial.
   Fafaj A, Lo Menzo E, Alaedeen D, Petro CC, et al · · 2022 · cited 8× · PMID 35704302 · DOI 10.1001/jamasurg.2022.2205
3. The association of permanent versus absorbable fixation on developing chronic post-herniorrhaphy groin pain in patients undergoing laparoscopic inguinal hernia repair.
   Woo KP, Ellis RC, Maskal SM, Remulla D, et al · · 2024 · cited 2× · PMID 38710888 · DOI 10.1007/s00464-024-10866-z