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

University Hospitals (UH) logo

University Hospitals (UH)

Status

Completed

Conditions

Cholelithiasis

Study type

Observational

Funder types

Other

Identifiers

NCT01117415
09-07-40 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

37 participants in 1 patient group

Gall Bladder Surgery
Description:
Who have symptomatic cholelithiasis and wish to undergo laparoscopic cholecystectomy for treatment.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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