Clinical trial NCT00535990: Minimally Invasive Surgery (MIS) Database for the Purpose of Research
Official title: Minimally Invasive Surgery (MIS) Database Looking at Patterns of Care, Outcomes, and Prognostic Analysis for the Purpose of Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Hernia
Colorectal Cancer
Laparoscopy
Keywords: Cholecystectomy
Appendectomy
Esophageal
Surgical
Procedures
Surgery
Gastric
bypass
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2007-09-27
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All male and female patients undergoing surgery at this center for either obesity surgery or for miimally invasive surgery.

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.

Eligibility 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.

Primary outcomes:
measure: Post Operative Outcomes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Santiago Horgan, MD
role: PRINCIPAL_INVESTIGATOR
References: