Gynecologic CancerNCT00671827
Evaluation of Robot-Assisted Surgery in Gynecologic Oncology
An observational study of Gynecologic Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
The goal of this observational study is to collect information about the length of surgery, the procedures performed during surgery, and any possible side effects of robot-assisted gynecologic cancer surgeries. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 588 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Apr 2008to 17 Dec 2020
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women who have undergone or will undergo a robotic-assisted gynecologic procedure at M. D. Anderson Cancer Center and St. Luke's Episcopal Hospital.
Who may be able to join
- 1) All women who have undergone or will undergo a robotic-assisted gynecologic procedure at MD Anderson Cancer Center and MD Anderson Banner - Arizona are eligible for inclusion in this study. They should be able to speak either English or Spanish.
Who cannot join
- 1) None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Anderson Banner Arizona
Gilbert, Arizona, 85234
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Prospective Evaluation of Robot-Assisted Surgery in Gynecologic Oncology
The goal of this observational study is to collect information about the length of surgery, the procedures performed during surgery, and any possible side effects of robot-assisted gynecologic cancer surgeries. The researchers also want to learn if patients who have robot-assisted surgeries have fewer complications during recovery.
Read the detailed description
Information Collection:
If you agree to take part in this study, the following information will be collected from your medical record after surgery:
- The reason you had or are scheduled to have robot-assisted surgery.
- How long the surgery took to complete.
- What procedures were performed during the surgery.
- If cancer was or was not found in the tissue that was removed.
- How long you were in the hospital.
- What complications, if any, happened that are related to the surgery.
Follow-Up Questionnaires:
Depending on when you enroll in the study, you may be asked to complete a short questionnaire 3 different times, each questionnaire will take less than 10 minutes to complete. If you had surgery for cervical cancer, you will complete the questionnaire 2 weeks after surgery. All patients will complete the questionnaires 4-6 weeks after surgery, and again 3-6 months later.
If you have your follow up care with a doctor outside of MD Anderson, you will be called to complete the questionnaires over the phone. Each phone call should last about 10 minutes This questionnaire and/or phone calls will ask questions about any side effects you have experienced that you think may be related to the surgery.
Length of Study:
After the last questionnaire is completed, your participation in the study is over.
This is an investigational study.
Up to 1,000 patients will take part in this study at MD Anderson Cancer Center and Banner MD Anderson Arizona.
- Conditions
- Gynecologic Cancer
- Being tested
- Questionnaire
- Keywords
- Gynecologic Cancer, Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer, Questionnaire, Survey, Robot-Assisted Surgery
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaires each taking less than 10 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Gynecologic Surgery | Patients who have undergone or will undergo a robotic-assisted gynecologic procedure. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection of Surgical Times, Procedures Performed, Intra-operative + Postoperative Complications of Robot-assisted Gynecologic Oncology Cases
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study start29 Apr 2008
- Primary completion17 Dec 2020
- Study completion17 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Case only
- Time perspective
- Other
- Enrolment
- 588 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Soliman, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671827
- Sponsor's protocol ID
- 2008-0122
- Status last verified
- Dec 2020
- First submitted
- 30 Apr 2008
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Robot-Assisted Surgery in Gynecologic Oncology
- ClinicalTrials.gov ID
- NCT00671827
- Acronym / sponsor ID
- 2008-0122
- Conditions
- Gynecologic Cancer
- Keywords
- Gynecologic Cancer, Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 588 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 29 Apr 2008 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 5 May 2008 (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.
The goal of this observational study is to collect information about the length of surgery, the procedures performed during surgery, and any possible side effects of robot-assisted gynecologic cancer surgeries. The researchers also want to learn if patients who have robot-assisted surgeries have fewer complications during recovery.
Detailed description
Information Collection:
If you agree to take part in this study, the following information will be collected from your medical record after surgery:
- The reason you had or are scheduled to have robot-assisted surgery.
- How long the surgery took to complete.
- What procedures were performed during the surgery.
- If cancer was or was not found in the tissue that was removed.
- How long you were in the hospital.
- What complications, if any, happened that are related to the surgery.
Follow-Up Questionnaires:
Depending on when you enroll in the study, you may be asked to complete a short questionnaire 3 different times, each questionnaire will take less than 10 minutes to complete. If you had surgery for cervical cancer, you will complete the questionnaire 2 weeks after surgery. All patients will complete the questionnaires 4-6 weeks after surgery, and again 3-6 months later.
If you have your follow up care with a doctor outside of MD Anderson, you will be called to complete the questionnaires over the phone. Each phone call should last about 10 minutes This questionnaire and/or phone calls will ask questions about any side effects you have experienced that you think may be related to the surgery.
Length of Study:
After the last questionnaire is completed, your participation in the study is over.
This is an investigational study.
Up to 1,000 patients will take part in this study at MD Anderson Cancer Center and Banner MD Anderson Arizona.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Gynecologic Surgery | – | Behavioral: QuestionnairePatients who have undergone or will undergo a robotic-assisted gynecologic procedure. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who have undergone or will undergo a robotic-assisted gynecologic procedure at M. D. Anderson Cancer Center and St. Luke's Episcopal Hospital.
Key inclusion criteria (1 listed)
- 1) All women who have undergone or will undergo a robotic-assisted gynecologic procedure at MD Anderson Cancer Center and MD Anderson Banner - Arizona are eligible for inclusion in this study. They should be able to speak either English or Spanish.
Key exclusion criteria (1 listed)
- 1) None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaires each taking less than 10 minutes to complete. | Behavioural | Robotic Gynecologic Surgery |
Primary outcome
Data Collection of Surgical Times, Procedures Performed, Intra-operative + Postoperative Complications of Robot-assisted Gynecologic Oncology Cases
Time frame: 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 21 Dec 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Pamela Soliman, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer, run by M.D. Anderson Cancer Center at 2 sites 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 1 inclusion and 1 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Data Collection of Surgical Times, Procedures Performed, Intra-operative + Postoperative Complications of Robot-assisted Gynecologic Oncology Cases (time frame: 5 Years). 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 21 Dec 2020.