Postoperative Urinary Retention Clinical Trial
— POUROfficial title:
The POUR Study: Effects of Neuromuscular Reversal Agents on Postoperative Urinary Retention (POUR) Following Laparoscopic Inguinal Hernia Repair
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
Status | Recruiting |
Enrollment | 140 |
Est. completion date | June 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Carolinas Medical Center | Charlotte | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | Merck Sharp & Dohme LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | 6 hours postop | |
Secondary | 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) | |
Secondary | Hospital Cost | Patient costs associated with procedure and hospital stay | At discharge (up to 365 days) | |
Secondary | 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) |
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