Clinical trial

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

Name

IRB00083113

Description

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

Trial arms

Trial start

2022-04-13

Estimated PCD

2024-12-01

Trial end

2025-06-01

Status

Recruiting

Phase

Early phase I

Treatment

Sugammadex

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.

Arms:

Sugammadex

Size

140

Primary endpoint

Number of participants with urinary retention

6 hours postop

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

Updated at

2024-02-28

1 organization

1 product

1 indication

Organization

Wake Forest University Health Sciences

Product

Sugammadex

Indication

Postoperative Urinary Retention