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

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00535990
First received: September 25, 2007
Last updated: August 27, 2010
Last verified: August 2010
  Purpose

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: 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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • measure patient outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: September 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535990

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

No publications provided

Responsible Party: Santiago Horgan, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00535990     History of Changes
Other Study ID Numbers: 070449, Internally funded
Study First Received: September 25, 2007
Last Updated: August 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Cholecystectomy
Appendectomy
Esophageal
Surgical
Procedures
Surgery
Gastric
bypass

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

ClinicalTrials.gov processed this record on September 16, 2014