Minimally Invasive Surgery (MIS) Database for the Purpose of Research
Study Details
Study Description
Brief Summary
The Minimally Invasive Surgery Team (MIST) are establishing a separate research database to find out more about patient's undergoing minimally invasive surgery (laparoscopic , open and robot assisted) procedures at UCSD. The hope is that collection of this information will give physicians a better knowledge and understanding of the benefits of minimally invasive surgery and possibly assist physicians to better manage future patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
Minimally invasive surgery has become the gold standard in surgical treatment for many indications, such as treatment of gallstones and acute appendicitis. For many other indications, the potential for minimally invasive approaches exist, but the data does not yet exist to establish it as the gold standard. In addition, there are certain patient factors such as age or weight that may influence the success of a minimally invasive procedure.
While there are numerous articles in the literature reporting outcomes for minimally invasive therapies, these series are often notable for small patient populations and varying definitions of treatment success from study to study. Due to the lack of uniformity in reporting patient outcomes, an opportunity exists to establish a standardized database of a large number of patients undergoing these procedures.
A standardized database will facilitate conducting prospective research of the risk factors and benefits of minimally invasive surgery. This analysis will not only enhance the care provided to these patients, it will reduce the use of ineffective therapy, thus promoting improved efficiency while increasing the quality of care provided within the UCSD system.
This is our initial application. Several other departments at UCSD have developed similar databases. There are numerous examples of prospective databases used for similar purposes in the literature. Smithers, et al, used a prospective database of 446 patients undergoing esophagectomy to compare open to laparoscopic outcomes. Nesset, et al, maintained a database of bariatric surgery patients for two decades and was able to draw conclusions from a data set of 1584 patients. Even at smaller numbers, a prospective database is useful. Andrew, et al, described the improvement in outcomes over the learning curve in the first 201 patients undergoing laparoscopic roux-en-Y gastric bypass using such a database. Though labor intensive, Clemmesen, et al, found maintaining a database allowed them to improve care for their patients.
Study Design
Outcome Measures
Primary Outcome Measures
- Post Operative Outcomes [1 year]
Post-operative outcomes including: 30 day morbidity 30 day mortality 30 day readmission Surgical site infection Surgical site occurrences Surgical Reintervention Specific Surgical outcomes (staple line leak, etc)
Eligibility Criteria
Criteria
Inclusion Criteria:
Gastric Banding Group:
- For gastric banding subjects to qualify for study inclusion, subjects have to have a BMI ranging from 33-40. Currently a BMI of 33 is our lower level of acceptable for bypass.
Control Group:
- All adult subjects 18 years or greater being seen in the minimally invasive surgery clinic for elective laparoscopic surgery will also be screened.
Exclusion Criteria:
- Subjects with a BMI>40 will be excluded because their fat cells are very large and therefore fragile and unsuitable for research use.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Diego | San Diego | California | United States | 92103 |
Sponsors and Collaborators
- University of California, San Diego
Investigators
- Principal Investigator: Santiago Horgan, MD, University of California, San Diego
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 070449
- Internally funded
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Surgical Intervention |
|---|---|
| Arm/Group Description | All patients in the minimally invasive surgery database are patients who have undergone surgical intervention by the Minimally Invasive Surgery faculty. Patients can be further stratified based on the type of procedure that they received. Since this study is primarily creation of a comprehensive database, patient's are not intentionally placed in a certain study arm aside from their procedure type. |
| Period Title: Overall Study | |
| STARTED | 250 |
| COMPLETED | 250 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Surgical Intervention |
|---|---|
| Arm/Group Description | All patients in the minimally invasive surgery database are patients who have undergone surgical intervention by the Minimally Invasive Surgery faculty. Patients can be further stratified based on the type of procedure that they received. Since this study is primarily creation of a comprehensive database, patient's are not intentionally placed in a certain study arm aside from their procedure type. |
| Overall Participants | 250 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
175
70%
|
| >=65 years |
75
30%
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
57
|
| Sex: Female, Male (Count of Participants) | |
| Female |
112
44.8%
|
| Male |
138
55.2%
|
Outcome Measures
| Title | Post Operative Outcomes |
|---|---|
| Description | Post-operative outcomes including: 30 day morbidity 30 day mortality 30 day readmission Surgical site infection Surgical site occurrences Surgical Reintervention Specific Surgical outcomes (staple line leak, etc) |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Surgical Intervention |
|---|---|
| Arm/Group Description | All patients in the minimally invasive surgery database are patients who have undergone surgical intervention by the Minimally Invasive Surgery faculty. Patients can be further stratified based on the type of procedure that they received. Since this study is primarily creation of a comprehensive database, patient's are not intentionally placed in a certain study arm aside from their procedure type. |
| Measure Participants | 250 |
| 30 day morbidity |
27
10.8%
|
| 30 day mortality |
0
0%
|
| 30 day readmission |
6
2.4%
|
| surgical site infection |
4
1.6%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Surgical Intervention | |
| Arm/Group Description | All patients in the minimally invasive surgery database are patients who have undergone surgical intervention by the Minimally Invasive Surgery faculty. Patients can be further stratified based on the type of procedure that they received. Since this study is primarily creation of a comprehensive database, patient's are not intentionally placed in a certain study arm aside from their procedure type. | |
All Cause Mortality |
||
| Surgical Intervention | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Surgical Intervention | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/250 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Surgical Intervention | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/250 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Jonathan Li |
|---|---|
| Organization | UCSD |
| Phone | 6618603471 |
| jzl023@health.ucsd.edu |
- 070449
- Internally funded