Colorectal Cancer, Hernia, Laparoscopy, Morbid Obesity
Conditions
Keywords
Cholecystectomy, Appendectomy, Esophageal, Surgical, Procedures, Surgery, Gastric, bypass
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.
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.
Interventions
None listed
Sponsors
University of California, San Diego
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surgical Intervention 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. | 250 |
| Total | 250 |
Baseline characteristics
| Characteristic | Surgical Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 75 Participants |
| Age, Categorical Between 18 and 65 years | 175 Participants |
| Age, Continuous | 57 years |
| Sex: Female, Male Female | 112 Participants |
| Sex: Female, Male Male | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 250 |
| serious Total, serious adverse events | 0 / 250 |
Outcome results
Primary
Post Operative Outcomes
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Surgical Intervention | Post Operative Outcomes | 30 day morbidity | 27 participants |
| Surgical Intervention | Post Operative Outcomes | 30 day mortality | 0 participants |
| Surgical Intervention | Post Operative Outcomes | 30 day readmission | 6 participants |
| Surgical Intervention | Post Operative Outcomes | surgical site infection | 4 participants |