Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy
Completed · Not applicable
Conditions studied: Cholelithiasis, Biliary Dyskinesia
In brief
Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of investigational surgery which uses the endoscope as the primary operative tool. The insertion sites for the endoscope include natural orifices such as the mouth, anus, vagina, or urethra. Multidisciplinary teams of surgeons and gastroenterologists collaborate to develop safe and effective surgical techniques via the natural orifice route in order to avoid surgical incisions. Early studies have focused on transvaginal surgery as the access route to the abdomen as it sidesteps troubling questions about infection and closure of the organ. This study is a pilot study to test the feasibility to NOTES transvaginal cholecystectomy using conventional surgical and endoscopic tools.
Key facts
- Study ID
- NCT00984100
- Run by
- Baystate Medical Center
- People needed
- 8
- Starts
- 2009-01-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2015-11-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Adult female (18 years old or over) patients who are able to provide informed consent for this surgical procedure
- Patients scheduled to undergo non-emergent surgical removal of the gallbladder
You may not qualify if…
- Inability to provide informed consent
- Patients who have a history of prior pelvic surgery (excluding Caesarian sections, tubal ligations, or non-operative pelviscopy)
- Patients who have acute cholecystitis, gallstone pancreatitis, or who have had a percutaneous cholecystotomy tube placed
- Patients with a BMI > 40 kg/m2
- Pregnancy
- Male gender
- History of PID
Where it is running
- Baystate Medical Center — Springfield, Massachusetts, United States
Full record on ClinicalTrials.gov
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