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The POUR (Postoperative Urinary Retention) Study (POUR)

Primary Purpose

Postoperative Urinary Retention

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sugammadex
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Urinary Retention focused on measuring Sugammadex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Carolinas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sugammadex

Retrospective cohort

Arm 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.

Retrospective cohort of patients who did not receive Sugammadex

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of stay (Days)
Patients will be followed from post surgery until discharge to determine the interim time
Hospital Cost
Patient costs associated with procedure and hospital stay
Quality of life - Carolinas Comfort Scale
Score range 0-115 . Lower scores indicate more favorable health

Full Information

First Posted
March 1, 2022
Last Updated
March 29, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05276804
Brief Title
The POUR (Postoperative Urinary Retention) Study
Acronym
POUR
Official Title
The POUR Study: Effects of Neuromuscular Reversal Agents on Postoperative Urinary Retention (POUR) Following Laparoscopic Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Urinary Retention
Keywords
Sugammadex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sugammadex
Arm Type
Experimental
Arm 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.
Arm Title
Retrospective cohort
Arm Type
No Intervention
Arm Description
Retrospective cohort of patients who did not receive Sugammadex
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with urinary retention
Description
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
Time Frame
6 hours postop
Secondary Outcome Measure Information:
Title
Length of stay (Days)
Description
Patients will be followed from post surgery until discharge to determine the interim time
Time Frame
From post up to discharge (up to 365 days)
Title
Hospital Cost
Description
Patient costs associated with procedure and hospital stay
Time Frame
At discharge (up to 365 days)
Title
Quality of life - Carolinas Comfort Scale
Description
Score range 0-115 . Lower scores indicate more favorable health
Time Frame
Postop clinic visit (typically 1-2 weeks post surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brant T Heniford, MD
Phone
704-355-3168
Email
Todd.Heniford@AtriumHealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory T Scarola, MS
Phone
704-355-5766
Email
Gregory.Scarola@AtriumHealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brant T Heniford, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brant T. Heniford, MD
Phone
704-355-1813
Email
Todd.Heniford@AtriumHealth.org
First Name & Middle Initial & Last Name & Degree
Brant T Heniford, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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The POUR (Postoperative Urinary Retention) Study

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