Cystostomy; ComplicationsNCT03032822
Opioid Consumption in Cystectomy Patients
An observational study of Cystostomy; Complications and Opioid Use, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystostomy; Complications, Opioid Use
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2018to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- patients undergoing cystectomy
- Capable and willing to consent
- Participants literate in English language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Opioid Consumption After Hospital Discharge in Cystectomy Patients
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.
Read the detailed description
Previous studies show that 67% of patients prescribed opioid medications in urologic procedures and surgeries had leftover opioid medications with a mean use of about half the medications prescribed. A similar study in thoracic surgery patients reported similar results with 71% of patients admitting to taking half or less of their prescribed opioid medications. Recent advancements in cystectomy protocol have already shown promise with reducing hospital length of stay from eight to four days, including the simultaneous reduction of opioid analgesics for pain management, with 4.9 mg morphine equivalents per day when using enhanced recovery techniques compared to 20.67 mg in traditional care. Results of the current prospective study could further support these results and include low to no risk assessments and follow-up phone calls. This study is observational and involves consenting adult patients undergoing cystectomy to pre-operative assessments including the Self Administered Gerocognitive Exam (SAGE) questionnaire, a cognitive test to identify mild-moderate cognitive impairment, and collection of demographic data and medical history. Phone call follow-ups include assessments of post-discharge pain and opioid consumption, and completing verbally an adapted Activities of Daily Living questionnaire. No additional risks have been identified by participating in this study. Participants may not directly benefit from participating in this trial, but the data collected could provide valuable insight into the discrepancy between required opioid pain medications and opioid pain medication prescription for adequate pain management. This insight could then be applied to reevaluate post-discharge pain management procedures and standards of care, therefore curbing opioid use and abuse trends
- Conditions
- Cystostomy; Complications, Opioid Use
- Keywords
- Opioid consumption, postdischarge, cystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Patients | All cystectomy patients who consent for the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: once per week, up to six weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start17 Jan 2018
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Why it stopped: Unable to collect accurate opioid consumption after discharge
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystostomy; ComplicationsStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tristan Weaver, Ohio State University
- Investigators
- Tristan E Weaver, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032822
- Sponsor's protocol ID
- 2017H0430
- Status last verified
- Mar 2024
- First submitted
- 24 Jan 2017
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Consumption After Hospital Discharge in Cystectomy Patients
- ClinicalTrials.gov ID
- NCT03032822
- Acronym / sponsor ID
- 2017H0430
- Conditions
- Cystostomy; Complications, Opioid Use
- Keywords
- Opioid consumption, postdischarge, cystectomy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to collect accurate opioid consumption after discharge
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Previous studies show that 67% of patients prescribed opioid medications in urologic procedures and surgeries had leftover opioid medications with a mean use of about half the medications prescribed. A similar study in thoracic surgery patients reported similar results with 71% of patients admitting to taking half or less of their prescribed opioid medications. Recent advancements in cystectomy protocol have already shown promise with reducing hospital length of stay from eight to four days, including the simultaneous reduction of opioid analgesics for pain management, with 4.9 mg morphine equivalents per day when using enhanced recovery techniques compared to 20.67 mg in traditional care. Results of the current prospective study could further support these results and include low to no risk assessments and follow-up phone calls. This study is observational and involves consenting adult patients undergoing cystectomy to pre-operative assessments including the Self Administered Gerocognitive Exam (SAGE) questionnaire, a cognitive test to identify mild-moderate cognitive impairment, and collection of demographic data and medical history. Phone call follow-ups include assessments of post-discharge pain and opioid consumption, and completing verbally an adapted Activities of Daily Living questionnaire. No additional risks have been identified by participating in this study. Participants may not directly benefit from participating in this trial, but the data collected could provide valuable insight into the discrepancy between required opioid pain medications and opioid pain medication prescription for adequate pain management. This insight could then be applied to reevaluate post-discharge pain management procedures and standards of care, therefore curbing opioid use and abuse trends
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | – | –All cystectomy patients who consent for the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- patients undergoing cystectomy
- Capable and willing to consent
- Participants literate in English language
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
opioid consumption over time
Time frame: once per week, up to six weeks after surgery
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
Results and safety
The study was stopped early (reason given: Unable to collect accurate opioid consumption after discharge). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tristan E Weaver, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystostomy; Complications and Opioid Use, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to collect accurate opioid consumption after discharge). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid consumption over time (time frame: once per week, up to six weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.