NCT03032822

Brief Summary

At the Ohio State University, and across the country, surgical patients admitted to the hospital are over-prescribed a significant amount of opioid medications upon discharge to home. Recent studies reveal that a large percentage of patients prescribed opioid medications after surgery have approximately half of the prescribed medication left over. This study aims to evaluate reported opioid use after surgery in patients undergoing cystectomy in order to better approach the issue with current opioid use and abuse trends while still providing adequate medical care and pain management to patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

January 17, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2024

Enrollment Period

3.7 years

First QC Date

January 24, 2017

Last Update Submit

March 24, 2025

Conditions

Keywords

Opioid consumptionpostdischargecystectomy

Outcome Measures

Primary Outcomes (1)

  • opioid consumption over time

    The opioid medication (oral morphine equivalent) taken by the patients will be assessed every week until the sixth postoperative week, to compare it with the amount prescribed by the physicians

    once per week, up to six weeks after surgery

Study Arms (1)

All Patients

All cystectomy patients who consent for the study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients at the OSUMC, 18 years of age and older scheduled to undergo a cystecotomy, who give written informed consent to participate in the study and who meet all inclusion and no exclusion criteria

You may qualify if:

  • patients undergoing cystectomy
  • Capable and willing to consent
  • Participants literate in English language

You may not qualify if:

  • History of drug and/or alcohol abuse/dependency
  • Ketamine use during hospitalization
  • Illiteracy
  • Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
  • Any condition that the principle investigator may disqualify the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Study Officials

  • Tristan E Weaver, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Clinical

Study Record Dates

First Submitted

January 24, 2017

First Posted

January 26, 2017

Study Start

January 17, 2018

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

March 27, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Efforts will be made to keep patient information confidential. individual participant data will only be available to researchers who are approved by the Institutional Review Board (IRB) to participate in study enrollment, follow up and data analysis.

Locations