Cost Effectiveness Analysis of Cholecystectomy, Projected Long Term Outcomes and Complications Evaluation

NCT ID: NCT01117415

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2010-06-30

Brief Summary

Participation in this research study does not involve any procedures. Health preference will be ascertained through standard techniques including time-tradeoff, standard gamble, and rating scale to assess risks regarding potential complications specific to NOTES (Natural Orifice Translumenal Endoscopic Surgery)gallbladder removal.

Detailed Description

The enticement of scarless surgery has created an unprecedented wave of enthusiasm and collaboration amongst surgeons, gastroenterologists, industry, and the lay public. However, major hurdles remain between current minimally invasive practices and the ultimate goal of safe, effective Natural Orifice Translumenal Endoscopic Surgery (NOTES). In an ideal world, these procedures should incur equivalent (or less) morbidity than current laparoscopic approaches and offer benefits of incisionless surgery. This idealism has been quickly tempered by the potential to create new and devastating complications with only minimal potential benefit to the patient. Several critical questions need to be answered. What probability of complication(s) are to be accepted? How will the potential benefits of NOTES be weighed against these new complications? What factors unique to NOTES will contribute to its cost effectiveness? The proposed study seeks to answer these questions before they occur. These results will give clinicians and investigators the necessary information with which to compare outcomes of NOTES and potentially alter techniques for safer, more effective interventions.

Conditions

Cholelithiasis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Gall Bladder Surgery

Who have symptomatic cholelithiasis and wish to undergo laparoscopic cholecystectomy for treatment.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Candidate of either sex
• 18 years old or above
• Have symptomatic cholelithiasis
• Wish to undergo laparoscopic cholecystectomy for treatment

Exclusion Criteria

• Not Applicable

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Marks, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin K. Poulose, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

09-07-40

Identifier Type: OTHER

Identifier Source: secondary_id

09-07-40

Identifier Type: -

Identifier Source: org_study_id