NCT00531219

Minimally Invasive Surgery: Using Natural Orifice Translumenal Endoscopic Surgery (NOTES)

Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transgastric Appendectomy and Cholecystectomy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study of pain and outcomes from patients undergoing transgastric NOTES removal of their appendix or gallbladder. Subjects who elect to have a transgastric NOTES removal of their appendix or gallbladder and agree to be in this study (through signature on the informed consent form) will be followed per standard of care, with additional follow-up for data collection including the following: * Subjects will complete a 7 day pain/temperature log after surgery * Subjects will receive a phone call at 6 months and at 1 year after surgery to capture data related to safety, adverse events, hospitalizations and patient satisfaction Additional data related to pain and outcomes will be collected at baseline/screening and at follow-up as necessary.

Conditions

• Appendicitis
• Cholelithiasis

Interventions

Type	Name	Description
PROCEDURE	Transgastric Appendectomy	The appendix will be removed through an incision in the stomach and pulled out through the mouth
PROCEDURE	Transgastric Cholecystectomy	The gallbladder will be removed through an incision in the stomach and pulled out through the mouth.

Timeline

• Start date: 2008-02-01
• Primary completion: 2018-12-01
• Completion: 2020-02-01
• First posted: 2007-09-18
• Last updated: 2018-05-01

Locations

1 site across 1 country: United States