The POUR (Postoperative Urinary Retention) Study

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The POUR Study: Effects of Neuromuscular Reversal Agents on Postoperative Urinary Retention (POUR) Following Laparoscopic Inguinal Hernia Repair

Conditions
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Postoperative Urinary Retention

Intervention / Treatment
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* Drug: Sugammadex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex<br>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. | Drug: Sugammadex<br>* 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.<br>|
| No Intervention: Retrospective cohort<br>Retrospective cohort of patients who did not receive Sugammadex | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay (Days) | Patients will be followed from post surgery until discharge to determine the interim time | From post up to discharge (up to 365 days) | 
| Hospital Cost | Patient costs associated with procedure and hospital stay | At discharge (up to 365 days) | 
| Quality of life - Carolinas Comfort Scale | Score range 0-115 . Lower scores indicate more favorable health | Postop clinic visit (typically 1-2 weeks post surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sugammadex