LaparoscopyNCT00490126
Data Collection of Demographics and Perioperative Care of Patients Undergoing Laparoscopic Surgery
An observational study of Laparoscopy, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to collect information on patients who had or are going to have laparoscopy performed at M. D. Anderson. Researchers want to use this information to learn the effects of laparoscopic surgery on patients over time. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Laparoscopy
- What is being tested?
- Laparoscopic Surgery Data Collection
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2006to 18 Sep 2018
- 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: All patients who had or will have laparoscopic surgery in the Department of Gynecologic Oncology (Gynecologic Oncology and General Gynecology) since January 1, 1990 forward.
Who may be able to join
- 1. All patients who had or will have laparoscopic surgery in the Department of Gynecologic Oncology (Gynecologic Oncology and General Gynecology) since January 1, 1990 forward.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Data Collection of Demographics and Perioperative Care of Patients Undergoing Laparoscopic Surgery in the Department of Gynecologic Oncology
The goal of this clinical research study is to collect information on patients who had or are going to have laparoscopy performed at M. D. Anderson. Researchers want to use this information to learn the effects of laparoscopic surgery on patients over time.
Read the detailed description
If you agree to take part in this study, your demographic information (such as your age, race, medical and surgical history, and type of cancer) will be collected. Information about the type of surgical procedure performed on you, your care during and after your surgery, any problems related to your surgery, and details about your follow-up care will be entered into a research database. This information will be collected from patients seen at M. D. Anderson since January 1, 1990. It will be used for future research studies.
The research database will be updated, after about 1 year, to include information on your disease outcome, treatment, and/or follow-up care. This information will be collected from your medical record, if possible. If it is not in your medical record, you may again be contacted so that researchers can learn this information.
Your participation in this study will continue up to 5 years after your laparoscopic procedure.
This is an investigational study. Up to 1,000 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Laparoscopy
- Being tested
- Laparoscopic Surgery Data Collection
- Keywords
- Laparoscopic Surgery, Laparoscopy, Gynecology, Demographics, Perioperative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Surgery Data CollectionOther
Prospectively and retrospectively collect data on patients who had laparoscopic surgery since January 1, 1990 forward. Data from the initial patient visit note, consultation notes, operative report, discharge summary, and follow-up progress notes will be entered into the database.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Surgery Database | Not described Receives: Other: Laparoscopic Surgery Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect, both prospectively and retrospectively, data on demographics, perioperative care, and patient outcomes in patients undergoing laparoscopic surgery.
Measured: 21 Years
Secondary outcomes (1)
Organize clinical information, patient characteristics, treatment, and laparoscopic outcome data into a single data repository, maintained in a secure platform that will provide an archive for future research.
Measured: 21 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study start15 Jun 2006
- Primary completion18 Sep 2018
- Study completion18 Sep 2018
Why it stopped: Not enough staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Ramirez, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490126
- Sponsor's protocol ID
- 2006-0170
- Status last verified
- Jan 2019
- First submitted
- 20 Jun 2007
- Last updated
- 15 Jan 2019
- 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 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection of Demographics and Perioperative Care of Patients Undergoing Laparoscopic Surgery in the Department of Gynecologic Oncology
- ClinicalTrials.gov ID
- NCT00490126
- Acronym / sponsor ID
- 2006-0170
- Conditions
- Laparoscopy
- Keywords
- Laparoscopic Surgery, Laparoscopy, Gynecology, Demographics, Perioperative Care
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough staff
- Enrolment
- 31 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 15 Jun 2006 (actual)
- Primary completion
- 18 Sep 2018 (actual)
- Study completion
- 18 Sep 2018 (actual)
- First posted
- 22 Jun 2007 (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 clinical research study is to collect information on patients who had or are going to have laparoscopy performed at M. D. Anderson. Researchers want to use this information to learn the effects of laparoscopic surgery on patients over time.
Detailed description
If you agree to take part in this study, your demographic information (such as your age, race, medical and surgical history, and type of cancer) will be collected. Information about the type of surgical procedure performed on you, your care during and after your surgery, any problems related to your surgery, and details about your follow-up care will be entered into a research database. This information will be collected from patients seen at M. D. Anderson since January 1, 1990. It will be used for future research studies.
The research database will be updated, after about 1 year, to include information on your disease outcome, treatment, and/or follow-up care. This information will be collected from your medical record, if possible. If it is not in your medical record, you may again be contacted so that researchers can learn this information.
Your participation in this study will continue up to 5 years after your laparoscopic procedure.
This is an investigational study. Up to 1,000 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Surgery Database | – | Other: Laparoscopic Surgery Data Collection |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who had or will have laparoscopic surgery in the Department of Gynecologic Oncology (Gynecologic Oncology and General Gynecology) since January 1, 1990 forward.
Key inclusion criteria (1 listed)
- 1. All patients who had or will have laparoscopic surgery in the Department of Gynecologic Oncology (Gynecologic Oncology and General Gynecology) since January 1, 1990 forward.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Laparoscopic Surgery Data CollectionProspectively and retrospectively collect data on patients who had laparoscopic surgery since January 1, 1990 forward. Data from the initial patient visit note, consultation notes, operative report, discharge summary, and follow-up progress notes will be entered into the database. | Other | Laparoscopic Surgery Database |
Primary outcome
Collect, both prospectively and retrospectively, data on demographics, perioperative care, and patient outcomes in patients undergoing laparoscopic surgery.
Time frame: 21 Years
1 secondary outcome
Organize clinical information, patient characteristics, treatment, and laparoscopic outcome data into a single data repository, maintained in a secure platform that will provide an archive for future research.
Time frame: 21 Years
Results and safety
The study was stopped early (reason given: Not enough staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- 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.
Pedro Ramirez, MD principal investigator
M.D. Anderson Cancer Center
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 Laparoscopy, run by M.D. Anderson 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 1 inclusion and 0 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 15 Jan 2019. 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: Not enough staff). 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?
Collect, both prospectively and retrospectively, data on demographics, perioperative care, and patient outcomes in patients undergoing laparoscopic surgery. (time frame: 21 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 15 Jan 2019.