The POUR (Postoperative Urinary Retention) Study

Wake Forest University (WFU)

Status and phase: Enrolling; Phase 3

Conditions: Postoperative Urinary Retention

Treatments: Drug: Sugammadex

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05276804

01-22-45E

IRB00083113

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Sugammadex

Experimental group

Description:

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.

Treatment:

Drug: Sugammadex

Retrospective cohort

No Intervention group

Description:

Retrospective cohort of patients who did not receive Sugammadex