Minimally Invasive Surgery (MIS) Database for the Purpose of Research

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00535990
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):
Santiago Horgan, University of California, San Diego

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
Morbid Obesity Hernia Colorectal Cancer Laparoscopy

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 Type : Observational
Actual Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Minimally Invasive Surgery (MIS) Database Looking at Patterns of Care, Outcomes, and Prognostic Analysis for the Purpose of Research
Study Start Date : September 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Primary Outcome Measures :
  1. measure patient outcomes [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00535990

United States, California
University of California, San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Principal Investigator: Santiago Horgan, MD University of California, San Diego

Responsible Party: Santiago Horgan, Professor of Surgery, University of California, San Diego Identifier: NCT00535990     History of Changes
Other Study ID Numbers: 070449
Internally funded
First Posted: September 27, 2007    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Santiago Horgan, University of California, San Diego:

Additional relevant MeSH terms:
Colorectal Neoplasms
Obesity, Morbid
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms