Clinical trial NCT05276804: The POUR (Postoperative Urinary Retention) Study
Official title: The POUR Study: Effects of Neuromuscular Reversal Agents on Postoperative Urinary Retention (POUR) Following Laparoscopic Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Urinary Retention
Keywords: Sugammadex
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-03-11
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

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

Primary outcomes:
measure: Number of participants with urinary retention
timeFrame: 6 hours postop
Secondary outcomes:
measure: Length of stay (Days)
timeFrame: From post up to discharge (up to 365 days)
measure: Hospital Cost
timeFrame: At discharge (up to 365 days)
measure: Quality of life - Carolinas Comfort Scale
timeFrame: Postop clinic visit (typically 1-2 weeks post surgery)
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Brant T Heniford, MD
role: PRINCIPAL_INVESTIGATOR
References: