CholelithiasisNOTESNCT01117415
Cost Effectiveness Analysis of Cholecystectomy, Projected Long Term Outcomes and Complications Evaluation
An observational study of Cholelithiasis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Participation in this research study does not involve any procedures. Health preference will be ascertained through standard techniques including time-tradeoff, standard gamble, and rating scale to assess risks regarding potential complications specific to NOTES (Natural Orifice Translumenal Endoscopic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholelithiasis
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jun 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participants will be recruited from the University Hospitals Case Medical Center Department of Surgery. The patient population in this study for the visual analog scale measurement, standard gamble questionnaire, and time trade-off questionnaire will be candidates of either sex, 18 years old or above, who have symptomatic cholelithiasis and wish to undergo laparoscopic cholecystectomy for treatment. The patients will be asked to participate in the study after evaluation by either the principal investigator, co-investigators, or study coordinator. The investigator will discuss the study with the patient and the study coordinator will participate in reviewing details and questions regarding the study if necessary. Patients will be recruited until 40 participants are enrolled.
Who may be able to join
- Candidate of either sex
- 18 years old or above
- Have symptomatic cholelithiasis
- Wish to undergo laparoscopic cholecystectomy for treatment
Who cannot join
- Not Applicable
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Cost Effectiveness Analysis of Transgastric Cholecystectomy, Transvaginal Cholecystectomy, and Laparoscopic Cholecystectomy: Projected Long Term Outcomes and Complications Evaluation
Participation in this research study does not involve any procedures. Health preference will be ascertained through standard techniques including time-tradeoff, standard gamble, and rating scale to assess risks regarding potential complications specific to NOTES (Natural Orifice Translumenal Endoscopic Surgery)gallbladder removal.
Read the detailed description
The enticement of scarless surgery has created an unprecedented wave of enthusiasm and collaboration amongst surgeons, gastroenterologists, industry, and the lay public. However, major hurdles remain between current minimally invasive practices and the ultimate goal of safe, effective Natural Orifice Translumenal Endoscopic Surgery (NOTES). In an ideal world, these procedures should incur equivalent (or less) morbidity than current laparoscopic approaches and offer benefits of incisionless surgery. This idealism has been quickly tempered by the potential to create new and devastating complications with only minimal potential benefit to the patient. Several critical questions need to be answered. What probability of complication(s) are to be accepted? How will the potential benefits of NOTES be weighed against these new complications? What factors unique to NOTES will contribute to its cost effectiveness? The proposed study seeks to answer these questions before they occur. These results will give clinicians and investigators the necessary information with which to compare outcomes of NOTES and potentially alter techniques for safer, more effective interventions.
- Conditions
- Cholelithiasis
- Keywords
- Gall Bladder, Cholecystectomy
- Medical subject headings
- Cholelithiasis
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 |
|---|---|---|
| Gall Bladder Surgery | Who have symptomatic cholelithiasis and wish to undergo laparoscopic cholecystectomy for treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare cost effectiveness data at one year postoperative
One year cost effectiveness data comparing transgastric cholecystectomy, transvaginal cholecystectomy, and laparoscopic cholecystectomy. Costs from two national databases: the State Ambulatory Surgery Database (SASD) and the NIS. The main outcome measure for this study will be cost per quality adjusted life year (QALY). Markov modeling techniques for model patient experiences for each of the procedures analyzed. Monte Carlo simulation will be used to calculate cost per QALY over a one year time span with determination of the incremental cost effectiveness ratio.
Measured: 1 year
Secondary outcomes (1)
Analyze the important factor that contributes to cost effectiveness at one year post operative.
Extensive sensitivity analyses of how individual factors (e.g. probability of gastric leak in transgastric cholecystectomy) impact cost effectiveness. Factors are varied over a clinically plausible range and their impact on cost effectiveness determined. One way and two way sensitivity analyses allow alterations of one or two factors simultaneously. Multiway sensitivity analysis using Monte Carlo simulation will be used to vary several variables simultaneously and to determine impact on cost effectiveness.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startApr 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical 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
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Marks, MD, University Hospitals Cleveland Medical Center
- Investigators
- Benjamin K. Poulose, MD, MPH, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117415
- Sponsor's protocol ID
- 09-07-40
- Other IDs
- 09-07-40
- Acronym
- NOTES
- Status last verified
- Jun 2015
- First submitted
- 12 Apr 2010
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness Analysis of Transgastric Cholecystectomy, Transvaginal Cholecystectomy, and Laparoscopic Cholecystectomy: Projected Long Term Outcomes and Complications Evaluation
- ClinicalTrials.gov ID
- NCT01117415
- Acronym / sponsor ID
- NOTES / 09-07-40
- Conditions
- Cholelithiasis
- Keywords
- Gall Bladder, Cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 May 2010 (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.
Participation in this research study does not involve any procedures. Health preference will be ascertained through standard techniques including time-tradeoff, standard gamble, and rating scale to assess risks regarding potential complications specific to NOTES (Natural Orifice Translumenal Endoscopic Surgery)gallbladder removal.
Detailed description
The enticement of scarless surgery has created an unprecedented wave of enthusiasm and collaboration amongst surgeons, gastroenterologists, industry, and the lay public. However, major hurdles remain between current minimally invasive practices and the ultimate goal of safe, effective Natural Orifice Translumenal Endoscopic Surgery (NOTES). In an ideal world, these procedures should incur equivalent (or less) morbidity than current laparoscopic approaches and offer benefits of incisionless surgery. This idealism has been quickly tempered by the potential to create new and devastating complications with only minimal potential benefit to the patient. Several critical questions need to be answered. What probability of complication(s) are to be accepted? How will the potential benefits of NOTES be weighed against these new complications? What factors unique to NOTES will contribute to its cost effectiveness? The proposed study seeks to answer these questions before they occur. These results will give clinicians and investigators the necessary information with which to compare outcomes of NOTES and potentially alter techniques for safer, more effective interventions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gall Bladder Surgery | – | –Who have symptomatic cholelithiasis and wish to undergo laparoscopic cholecystectomy for treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be recruited from the University Hospitals Case Medical Center Department of Surgery. The patient population in this study for the visual analog scale measurement, standard gamble questionnaire, and time trade-off questionnaire will be candidates of either sex, 18 years old or above, who have symptomatic cholelithiasis and wish to undergo laparoscopic cholecystectomy for treatment. The patients will be asked to participate in the study after evaluation by either the principal investigator, co-investigators, or study coordinator. The investigator will discuss the study with the patient and the study coordinator will participate in reviewing details and questions regarding the study if necessary. Patients will be recruited until 40 participants are enrolled.
Key inclusion criteria (4 listed)
- Candidate of either sex
- 18 years old or above
- Have symptomatic cholelithiasis
- Wish to undergo laparoscopic cholecystectomy for treatment
Key exclusion criteria (1 listed)
- Not Applicable
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
Compare cost effectiveness data at one year postoperative
Time frame: 1 year
One year cost effectiveness data comparing transgastric cholecystectomy, transvaginal cholecystectomy, and laparoscopic cholecystectomy. Costs from two national databases: the State Ambulatory Surgery Database (SASD) and the NIS. The main outcome measure for this study will be cost per quality adjusted life year (QALY). Markov modeling techniques for model patient experiences for each of the procedures analyzed. Monte Carlo simulation will be used to calculate cost per QALY over a one year time span with determination of the incremental cost effectiveness ratio.
1 secondary outcome
Analyze the important factor that contributes to cost effectiveness at one year post operative.
Time frame: One year
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 8 Jun 2015.
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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.
Benjamin K. Poulose, MD, MPH principal investigator
University Hospitals Cleveland Medical 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 Cholelithiasis, run by University Hospitals Cleveland Medical 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 4 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 8 Jun 2015. 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?
Compare cost effectiveness data at one year postoperative (time frame: 1 year). 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 8 Jun 2015.