Trial Outcomes & Findings for Urinary Retention After Laparoscopic Inguinal Hernia Repair: Comparing the Use of the Intraoperative Urinary Catheter (NCT NCT03835351)
NCT ID: NCT03835351
Last Updated: 2022-05-03
Results Overview
The rate of postoperative urinary retention requiring insertion of a urinary catheter
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
491 participants
Primary outcome timeframe
From the day of surgery until postoperative day 30
Results posted on
2022-05-03
Participant Flow
Participant milestones
| Measure |
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.
Urinary Catheter: 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
|
|---|---|---|
|
Overall Study
STARTED
|
241
|
250
|
|
Overall Study
COMPLETED
|
241
|
250
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Urinary Retention After Laparoscopic Inguinal Hernia Repair: Comparing the Use of the Intraoperative Urinary Catheter
Baseline characteristics by cohort
| Measure |
Intraoperative Urinary Catheter
n=241 Participants
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
n=250 Participants
No intraoperative urinary catheter will be used during the case
|
Total
n=491 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 Years
n=5 Participants
|
62 Years
n=7 Participants
|
61 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
232 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
465 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, not of Hispanic Origin
|
18 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, not of Hispanic Origin
|
209 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
413 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
241 participants
n=5 Participants
|
250 participants
n=7 Participants
|
491 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the day of surgery until postoperative day 30The rate of postoperative urinary retention requiring insertion of a urinary catheter
Outcome measures
| Measure |
Intraoperative Urinary Catheter
n=241 Participants
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
n=250 Participants
No intraoperative urinary catheter will be used during the case
|
|---|---|---|
|
Number of Participants With Post Operative Urinary Retention
|
23 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Measured from Beginning of Anesthesia to the End of Anesthesia and up to 4 hours Post OperativelyThis will be determined by comparing the rates of intraoperative bladder injuries between the two study groups
Outcome measures
| Measure |
Intraoperative Urinary Catheter
n=241 Participants
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
n=250 Participants
No intraoperative urinary catheter will be used during the case
|
|---|---|---|
|
Number of Participants With Intraoperative Bladder Injuries
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the day of surgery until postoperative day 30This will be accomplished by analyzing the rates of urinary tract injury, infections and bladder injuries due to intraoperative catheter placement.
Outcome measures
| Measure |
Intraoperative Urinary Catheter
n=241 Participants
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
n=250 Participants
No intraoperative urinary catheter will be used during the case
|
|---|---|---|
|
Number of Participants Who Have Complications From Intra-operative Urinary Catheter
Intraop Complication Urethral Trauma
|
1 participants
|
0 participants
|
|
Number of Participants Who Have Complications From Intra-operative Urinary Catheter
Intraop Complication, other
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From the day of surgery until postoperative day 30This 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.
Outcome measures
| Measure |
Intraoperative Urinary Catheter
n=241 Participants
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
n=250 Participants
No intraoperative urinary catheter will be used during the case
|
|---|---|---|
|
Number of Participants With Complications Urinary Catheter Who Develop Retention
Urinary Tract Injury
|
1 Participants
|
0 Participants
|
|
Number of Participants With Complications Urinary Catheter Who Develop Retention
Bladder Injuries
|
0 Participants
|
0 Participants
|
|
Number of Participants With Complications Urinary Catheter Who Develop Retention
Infection
|
21 Participants
|
28 Participants
|
|
Number of Participants With Complications Urinary Catheter Who Develop Retention
None
|
219 Participants
|
222 Participants
|
Adverse Events
Intraoperative Urinary Catheter
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
No Intraoperative Urinary Catheter
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intraoperative Urinary Catheter
n=241 participants at risk
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
n=250 participants at risk
No intraoperative urinary catheter will be used during the case
|
|---|---|---|
|
Renal and urinary disorders
Urethra Injury
|
0.41%
1/241 • Number of events 1 • 30 days following surgery
|
0.00%
0/250 • 30 days following surgery
|
Other adverse events
| Measure |
Intraoperative Urinary Catheter
n=241 participants at risk
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
n=250 participants at risk
No intraoperative urinary catheter will be used during the case
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia Requiring Transfusion
|
0.41%
1/241 • Number of events 1 • 30 days following surgery
|
0.00%
0/250 • 30 days following surgery
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/241 • 30 days following surgery
|
0.40%
1/250 • Number of events 1 • 30 days following surgery
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/241 • 30 days following surgery
|
0.40%
1/250 • Number of events 1 • 30 days following surgery
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.00%
0/241 • 30 days following surgery
|
0.80%
2/250 • Number of events 2 • 30 days following surgery
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/241 • 30 days following surgery
|
0.40%
1/250 • Number of events 1 • 30 days following surgery
|
|
Infections and infestations
Urinary Tract Infection
|
0.83%
2/241 • Number of events 2 • 30 days following surgery
|
2.4%
6/250 • Number of events 6 • 30 days following surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place