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| ID | Type | Description | Link |
|---|---|---|---|
| 01-22-45E | Other Identifier | Atrium |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Experimental | 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. |
|
| Retrospective cohort | No Intervention | Retrospective cohort of patients who did not receive Sugammadex |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 hours postop |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay (Days) | Patients will be followed from post surgery until discharge to determine the interim time | From post op to discharge (up to 365 days) |
| Hospital Cost | Patient costs associated with procedure and hospital stay |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 2 |
Inclusion Criteria:
Exclusion Criteria:
laparoscopic cholecystectomy)
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| Name | Affiliation | Role |
|---|---|---|
| Brant T Heniford, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
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74 prospectively enrolled into Sugammadex group 74 retrospectively matched from baseline (non-Sugammadex) group
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Retrospective Cohort | Retrospective cohort of patients who did not receive Sugammadex |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at time of surgery, in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 6 hours postop |
|
Up to Week 2
Number of adverse events reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory T. Scarola | Atrium Health | 704 355-5379 | gregory.scarola@advocatehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2022 | Mar 27, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 20, 2023 | Jan 30, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| At discharge (up to 365 days) |
| Operation Time |
Number of minutes the operation lasted |
| Day 1 |
| 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. | Day 1 |
| 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. | Up to Week 2 |
| BG001 | Retrospective Cohort | Retrospective cohort of patients who did not receive Sugammadex |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count and percentage of males and females | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Race of participants | Count of Participants | Participants | No |
|
| History of BPH (Benign prostatic hyperplasia) | Count of BPH history | Count of Participants | Participants | No |
|
| Side of Inguinal Repair | Bilateral vs Unilateral Repair | Count of Participants | Participants | No |
|
| Surgical Repair Technique | Planned operative technique for inguinal hernia repair | Count of Participants | Participants | No |
|
| Tobacco Status | Tobacco status of the participant at time baseline | Count of Participants | Participants | No |
|
| Primary vs Recurrent Repair | Primary or recurrent hernia repair | Count of Participants | Participants | No |
|
| Diabetes Status | Diabetes Status at time of surgery | Count of Participants | Participants | No |
|
| Steroids Use | Steroids use at time of surgery | Count of Participants | Participants | No |
|
| OG001 |
| Retrospective Cohort |
Retrospective cohort of patients who did not receive Sugammadex |
|
|
| Secondary | Length of Stay (Days) | Patients will be followed from post surgery until discharge to determine the interim time | Posted | Mean | Standard Deviation | Days | From post op to discharge (up to 365 days) |
|
|
|
| Secondary | Hospital Cost | Patient costs associated with procedure and hospital stay | Posted | Mean | Standard Deviation | USD | At discharge (up to 365 days) |
|
|
|
| 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. | This outcome measure type was entered incorrectly when the study was initially registered. The QOL survey should have been designated as "other." | Posted | Week 2 |
|
|
| Other Pre-specified | Operation Time | Number of minutes the operation lasted | Posted | Mean | Standard Deviation | minutes | Day 1 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | milligrams | Day 1 |
|
|
|
| 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. | Posted | Number | participants | Up to Week 2 |
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | Retrospective Cohort | Retrospective cohort of patients who did not receive Sugammadex | 0 | 74 | 0 | 74 | 0 | 74 |
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| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |