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Minimally Invasive Surgery (MIS) Database Looking at Patterns of Care, Outcomes, and Prognostic Analysis for the Purpose of Research

18 Years
Not Enrolling
Morbid Obesity, Hernia, Colorectal Cancer, Laparoscopy

Thank you

Trial Information

Minimally Invasive Surgery (MIS) Database Looking at Patterns of Care, Outcomes, and Prognostic Analysis for the Purpose of Research

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

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.

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

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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

measure patient outcomes

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Santiago Horgan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Diego


United States: Institutional Review Board

Study ID:




Start Date:

September 2007

Completion Date:

November 2009

Related Keywords:

  • Morbid Obesity
  • Hernia
  • Colorectal Cancer
  • Laparoscopy
  • Cholecystectomy
  • Appendectomy
  • Esophageal
  • Surgical
  • Procedures
  • Surgery
  • Gastric
  • bypass
  • Colorectal Neoplasms
  • Hernia
  • Obesity
  • Obesity, Morbid



University of California, San Diego La Jolla, California  92037-1709