![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsored by: |
University of California, San Diego |
---|---|
Information provided by: | University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT00535990 |
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 |
---|
Morbid Obesity Hernia Colorectal Cancer Laparoscopy |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Minimally Invasive Surgery (MIS) Database Looking at Patterns of Care, Outcomes, and Prognostic Analysis for the Purpose of Research |
Estimated Enrollment: | 1000 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
All male and female patients undergoing surgery at this center for either obesity surgery or for miimally invasive surgery.
Inclusion Criteria:
Gastric Banding Group:
Control Group:
Exclusion Criteria:
Contact: Julie A Bosia, BSN | 619-471-0774 | jbosia@ucsd.edu |
Contact: Christina Chickering | 619-471-0701 | cechickering@ucsd.edu |
United States, California | |
University of California, San Diego | Recruiting |
San Diego, California, United States, 92103 | |
Principal Investigator: Santiago Horgan, MD | |
Sub-Investigator: Mark Talamini, MD | |
Sub-Investigator: Sonia Ramamoorthy, MD | |
Sub-Investigator: David W Easter, MD | |
Sub-Investigator: Bryan Sandler, MD | |
Sub-Investigator: Garth Jacobsen, MD |
Principal Investigator: | Santiago Horgan, MD | University of California, San Diego |
Responsible Party: | University of California, San Diego ( Santiago Horgan, MD ) |
Study ID Numbers: | 070449, Internally funded |
Study First Received: | September 25, 2007 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00535990 History of Changes |
Health Authority: | United States: Institutional Review Board |
Cholecystectomy Appendectomy Esophageal Surgical |
Procedures Surgery Gastric bypass |
Obesity Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Overweight Obesity, Morbid Intestinal Diseases Rectal Diseases Intestinal Neoplasms Body Weight |
Signs and Symptoms Digestive System Diseases Esophageal Disorder Hernia Nutrition Disorders Gastrointestinal Neoplasms Overnutrition Esophageal Diseases Colorectal Neoplasms |
Obesity Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Overweight Obesity, Morbid Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Body Weight Signs and Symptoms Neoplasms Neoplasms by Site Digestive System Diseases Nutrition Disorders Gastrointestinal Neoplasms Overnutrition Colorectal Neoplasms |