Postoperative Urinary Retention
Conditions
Keywords
Sugammadex
Brief summary
The primary aim of this study will be to compare the rate of postoperative urinary retention between patients receiving Sugammadex and those receiving traditional reversal agents
Detailed description
Postoperative urinary retention following laparoscopic inguinal hernia repair occurs in approximately one out of ten patients. The more rapid reversal of neuromuscular blockade with Sugammadex has empirically been associated with low rates of postoperative urinary retention. In this study, patients will receive Sugammadex following laparoscopic inguinal hernia repair and then be retrospectively matched against a group of patients who did not receive Sugammadex. The primary aim of this study will be to compare the rate of postoperative urinary retention between patients receiving Sugammadex and those receiving traditional reversal agents (e.g. neostigmine which has a retention rate of 5-11%). We will also examine difference in cost and quality of life between the two groups. Our hypothesis is that the use of Sugammadex will decrease rate of postoperative urinary retention, decrease associated cost, such as need for admission, and not negatively impact quality of life.
Interventions
DRUGSugammadex
The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.
Sponsors
Merck Sharp & Dohme LLC
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over the age of 18 * Undergoing laparoscopic inguinal hernia repair at Carolinas Medical Center by attending surgeons within the Division of Gastrointestinal and Minimally Invasive Surgery * Unilateral or bilateral inguinal hernia repair; may have concurrent umbilical hernia repair performed * Agreeable to participation in the study
Exclusion criteria
* Patients who are having concurrent ventral or flank hernias repaired at time of operation or are having an inguinal hernia repair along with another operation (e.g. laparoscopic cholecystectomy) * End-stage renal disease (Creatinine clearance less than 30) * Neuromuscular disease * Prior adverse reactions to Sugammadex * Patients who do not provide consent for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Urinary Retention | 6 hours postop | Urinary retention is defined as the inability to void at six hours postoperatively, which will be recorded in the postoperative recovery area and the same definition for urinary retention will be applied to the comparative retrospective cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay (Days) | From post op to discharge (up to 365 days) | Patients will be followed from post surgery until discharge to determine the interim time |
| Hospital Cost | At discharge (up to 365 days) | Patient costs associated with procedure and hospital stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Survey | Week 2 | Quality of life survey given post hernia repair to evaluate mesh sensation, pain and movement limitations. 23 total items. Each item is scored 0 (no symptoms) to 5 (disabling symptoms). Total score range is 0-115 with a low score indicating surgery had no negative impact on quality of life. |
| Number of Participants With Clean Wounds at Follow Up | Up to Week 2 | Number of participants with clean wounds based on the Center for Disease Control and Prevention (CDC) Wound guidelines. CDC wound classification options are Clean, Clean-Contaminated, Contaminated, and Dirty/Infected. |
| Operation Time | Day 1 | Number of minutes the operation lasted |
| Morphine Milligram Equivalents | Day 1 | Morphine milligram equivalents (MME) represents the potency of an opioid dose relative to morphine. MME is intended to help clinicians make safe, appropriate decisions concerning changes to opioid regimens. |
Countries
United States
Participant flow
Recruitment details
74 prospectively enrolled into Sugammadex group 74 retrospectively matched from baseline (non-Sugammadex) group
Participants by arm
| Arm | Count |
|---|---|
| Sugammadex Prospective cohort of patients undergoing laparoscopic inguinal hernia repair will receive Sugammadex. Sugammadex will be used for reversal of their neuromuscular blockade. The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required. | 74 |
| Retrospective Cohort Retrospective cohort of patients who did not receive Sugammadex | 74 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | screen failure | 23 | 0 |
Baseline characteristics
| Characteristic | Total | Sugammadex | Retrospective Cohort |
|---|---|---|---|
| Age, Continuous | 59.3 Years STANDARD_DEVIATION 15 | 59.4 Years STANDARD_DEVIATION 15.5 | 59.2 Years STANDARD_DEVIATION 14.6 |
| Diabetes Status No | 141 Participants | 68 Participants | 73 Participants |
| Diabetes Status Yes | 7 Participants | 6 Participants | 1 Participants |
| History of BPH (Benign prostatic hyperplasia) No | 123 Participants | 64 Participants | 59 Participants |
| History of BPH (Benign prostatic hyperplasia) Yes | 25 Participants | 10 Participants | 15 Participants |
| Primary vs Recurrent Repair Primary | 127 Participants | 63 Participants | 64 Participants |
| Primary vs Recurrent Repair Recurrent | 21 Participants | 11 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 11 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 121 Participants | 62 Participants | 59 Participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Male | 139 Participants | 69 Participants | 70 Participants |
| Side of Inguinal Repair Bilateral | 57 Participants | 30 Participants | 27 Participants |
| Side of Inguinal Repair Unilateral | 91 Participants | 44 Participants | 47 Participants |
| Steroids Use No | 135 Participants | 69 Participants | 66 Participants |
| Steroids Use Yes | 13 Participants | 5 Participants | 8 Participants |
| Surgical Repair Technique Laparoscopic | 94 Participants | 35 Participants | 59 Participants |
| Surgical Repair Technique Robotic | 54 Participants | 39 Participants | 15 Participants |
| Tobacco Status Current | 16 Participants | 5 Participants | 11 Participants |
| Tobacco Status Former | 51 Participants | 30 Participants | 21 Participants |
| Tobacco Status Never | 81 Participants | 39 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 74 |
| other Total, other adverse events | 0 / 74 | 0 / 74 |
| serious Total, serious adverse events | 0 / 74 | 0 / 74 |
Outcome results
Primary
Number of Participants With Urinary Retention
Urinary retention is defined as the inability to void at six hours postoperatively, which will be recorded in the postoperative recovery area and the same definition for urinary retention will be applied to the comparative retrospective cohort
Time frame: 6 hours postop
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sugammadex | Number of Participants With Urinary Retention | Yes | 0 Participants |
| Sugammadex | Number of Participants With Urinary Retention | No | 74 Participants |
| Retrospective Cohort | Number of Participants With Urinary Retention | Yes | 11 Participants |
| Retrospective Cohort | Number of Participants With Urinary Retention | No | 63 Participants |
Secondary
Hospital Cost
Patient costs associated with procedure and hospital stay
Time frame: At discharge (up to 365 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Hospital Cost | 57954 USD | Standard Deviation 13448 |
| Retrospective Cohort | Hospital Cost | 54970 USD | Standard Deviation 19324 |
Secondary
Length of Stay (Days)
Patients will be followed from post surgery until discharge to determine the interim time
Time frame: From post op to discharge (up to 365 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Length of Stay (Days) | 0.0 Days | Standard Deviation 0.1 |
| Retrospective Cohort | Length of Stay (Days) | 0.3 Days | Standard Deviation 0.9 |
Other Pre-specified
Morphine Milligram Equivalents
Morphine milligram equivalents (MME) represents the potency of an opioid dose relative to morphine. MME is intended to help clinicians make safe, appropriate decisions concerning changes to opioid regimens.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Morphine Milligram Equivalents | 38.3 milligrams | Standard Deviation 11.9 |
| Retrospective Cohort | Morphine Milligram Equivalents | 38.0 milligrams | Standard Deviation 17.8 |
Other Pre-specified
Number of Participants With Clean Wounds at Follow Up
Number of participants with clean wounds based on the Center for Disease Control and Prevention (CDC) Wound guidelines. CDC wound classification options are Clean, Clean-Contaminated, Contaminated, and Dirty/Infected.
Time frame: Up to Week 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sugammadex | Number of Participants With Clean Wounds at Follow Up | 74 participants |
| Retrospective Cohort | Number of Participants With Clean Wounds at Follow Up | 74 participants |
Other Pre-specified
Operation Time
Number of minutes the operation lasted
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Operation Time | 105.9 minutes | Standard Deviation 26.8 |
| Retrospective Cohort | Operation Time | 102.1 minutes | Standard Deviation 51.3 |
Other Pre-specified
Quality of Life Survey
Quality of life survey given post hernia repair to evaluate mesh sensation, pain and movement limitations. 23 total items. Each item is scored 0 (no symptoms) to 5 (disabling symptoms). Total score range is 0-115 with a low score indicating surgery had no negative impact on quality of life.
Time frame: Week 2
Population: This outcome measure type was entered incorrectly when the study was initially registered. The QOL survey should have been designated as other.