Endometrial CancerNCT00909896
Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy
An observational study of Endometrial Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study is being done to evaluate the efficacy of robotic approach for staging of endometrial cancer as compared to an equivalent abdominal approach. The primary objective is to measure and compare postoperative pain at rest at several time points between two groups of patients undergoing either robotic or open… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2009to 29 Jan 2013
- 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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female subjects ages 18-85 years old, Pre operative diagnosis of clinical stage I or II endometrial cancer, Subject able to tolerate use of opioids for pain management, Eastern Cooperative Oncology Group (ECOG)0-3.
Who may be able to join
- Female subjects between ages 18-86 years old
- Subject provided written consent
- Preoperative diagnosis of stage i or II endometrial cancer
- Subject scheduled to undergo robotic hysterectomy or open abdominal hysterectomy at The Ohio State University
- Subject should be expected to be able to use and tolerate opioids for pain management
- Pre operative health is graded as ASA I-III
- ECOG(Eastern Cooperative Oncology Group)Performance status 0-3
- Subject willing to comply with scheduled visits
Who cannot join
- Subject is prisoner, pregnant, or under age 18 or over age 85
- Hypersensitivity to opioids
- subject is breastfeeding
- Preoperative Health grade ASA IV-V
- ECOG Performance Status 4-5
- History of receiving prior chemotherapy or radiation therapy
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- Subject schedule for additional procedures at the same time as the surgical staging
- Subject with pain related illness that to the PI discretion would interfere with study assessments.
- Known history of alcohol, analgesic, or narcotic abuse within 12 months.
- Subjects taking NSAID(nonsteroidal anti inflammatory drug medications)within 7 days prior to baseline visit.
- Require and/or receive chronic analgesic therapy for any pain related condition
- Severe acute or chronic medical or psychiatric condition that would interfere with the study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Double Arm, Comparative Study for the Evaluation of Postoperative Pain, QOL, and Determination of Inflammatory Markers In Patients Undergoing Robotics Versus Open Laparotomy Approach for Staging of Endometrial Cancer
This study is being done to evaluate the efficacy of robotic approach for staging of endometrial cancer as compared to an equivalent abdominal approach. The primary objective is to measure and compare postoperative pain at rest at several time points between two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer.
Read the detailed description
The primary objective is to measure and compare postoperative pain at rest at several time points (24 +/-4hours, 48 +/-4hours, and 72 +/-4hours) between the two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer. Post operative Quality of Life will also be collected at several time points. The total amount of post operative opioid requirements during the first 24hours between patients undergoing either robotic or open laparotomy approach surgery. The survival status every four months for the first two years will be monitored, then every 6 months for up to 5 years. The primary endpoint is the mean difference in post operative pain VAS scores reported by subjects at rest at the following time points: 24+/-4, 48+/-4, and 72+/-4 hours between both groups after surgery has been completed.
- Conditions
- Endometrial Cancer
- Keywords
- endometrial, pain
- Medical subject headings
- Endometrial Neoplasms, Pain
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 |
|---|---|---|
| Robotic Surgery candidates | Group of patients receive Robotic approach for endometrial cancer staging | |
| Open Laparotomy Surgical Candidates | Patients receiving open laparotomy for endometrial cancer surgical staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcome measure is mean difference in post operative pain VAS scores reported by subjects at rest at the several time points between two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer.
Measured: up to 24 hours
Secondary outcomes (1)
Secondary outcomes will include the measurement of post operative pain after leg extension, post operative quality of life, post operative opioid requirements during first 24hours, survival status up to five years.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study start8 Apr 2009
- Primary completion29 Jan 2013
- Study completion29 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- 142 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Cohn, Ohio State University Comprehensive Cancer Center
- Investigators
- David Cohn, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909896
- Sponsor's protocol ID
- OSU-08155
- Status last verified
- Mar 2018
- First submitted
- 28 May 2009
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double Arm, Comparative Study for the Evaluation of Postoperative Pain, QOL, and Determination of Inflammatory Markers In Patients Undergoing Robotics Versus Open Laparotomy Approach for Staging of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT00909896
- Acronym / sponsor ID
- OSU-08155
- Conditions
- Endometrial Cancer
- Keywords
- endometrial, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 8 Apr 2009 (actual)
- Primary completion
- 29 Jan 2013 (actual)
- Study completion
- 29 Jan 2013 (actual)
- First posted
- 29 May 2009 (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.
This study is being done to evaluate the efficacy of robotic approach for staging of endometrial cancer as compared to an equivalent abdominal approach. The primary objective is to measure and compare postoperative pain at rest at several time points between two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer.
Detailed description
The primary objective is to measure and compare postoperative pain at rest at several time points (24 +/-4hours, 48 +/-4hours, and 72 +/-4hours) between the two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer. Post operative Quality of Life will also be collected at several time points. The total amount of post operative opioid requirements during the first 24hours between patients undergoing either robotic or open laparotomy approach surgery. The survival status every four months for the first two years will be monitored, then every 6 months for up to 5 years. The primary endpoint is the mean difference in post operative pain VAS scores reported by subjects at rest at the following time points: 24+/-4, 48+/-4, and 72+/-4 hours between both groups after surgery has been completed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Surgery candidates | – | –Group of patients receive Robotic approach for endometrial cancer staging |
| Open Laparotomy Surgical Candidates | – | –Patients receiving open laparotomy for endometrial cancer surgical staging |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female subjects ages 18-85 years old, Pre operative diagnosis of clinical stage I or II endometrial cancer, Subject able to tolerate use of opioids for pain management, Eastern Cooperative Oncology Group (ECOG)0-3.
Key inclusion criteria (8 listed)
- Female subjects between ages 18-86 years old
- Subject provided written consent
- Preoperative diagnosis of stage i or II endometrial cancer
- Subject scheduled to undergo robotic hysterectomy or open abdominal hysterectomy at The Ohio State University
- Subject should be expected to be able to use and tolerate opioids for pain management
Key exclusion criteria (12 listed)
- Subject is prisoner, pregnant, or under age 18 or over age 85
- Hypersensitivity to opioids
- subject is breastfeeding
- Preoperative Health grade ASA IV-V
- ECOG Performance Status 4-5
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
The outcome measure is mean difference in post operative pain VAS scores reported by subjects at rest at the several time points between two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer.
Time frame: up to 24 hours
1 secondary outcome
Secondary outcomes will include the measurement of post operative pain after leg extension, post operative quality of life, post operative opioid requirements during first 24hours, survival status up to five years.
Time frame: up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- JameslineLink provided by the sponsor.
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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.
David Cohn, 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 Endometrial Cancer, run by Ohio State University Comprehensive Cancer Center 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 2 Apr 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The outcome measure is mean difference in post operative pain VAS scores reported by subjects at rest at the several time points between two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer. (time frame: up to 24 hours). 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 2 Apr 2018.