Recruiting

NOTES

Sponsor:

UCLA

Code:

NCT00531219

Conditions

Appendicitis

Cholelithiasis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transgastric Appendectomy

Transgastric Cholecystectomy

Study Details

Brief 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

Study ID

NCT00531219

Start date

Feb, 2008

Status verified date

Apr, 2018

Completion date

Feb, 2020

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion criteria for the Group #1 transgastric appendectomy:

1. Males and Females between the ages of 18-75
2. Clinical diagnosis of appendicitis Emergency room evaluation within 36 hours of the onset of pain
3. ASA classification I
4. Mentally competent to give informed consent.
5. Scheduled to undergo a transgastric NOTES appendectomy.

Exclusion criteria for group #1 transgastric appendectomy:

1. Pregnant women
2. Morbidly obese patients (Body mass index > 35)
3. Patients who are taking immunosuppressive medications or are immunocompromised
4. Patients who are on Proton Pump Inhibitors (PPI)
5. Patients with evidence of an abdominal abscess or mass on CT scan
6. Patients who present with a clinical diagnosis of sepsis
7. Patients who have a history of open abdominal surgery
8. Patients with diffuse peritonitis
9. Patients on blood thinners or aspirin

Inclusion criteria for Group #2 transgastric cholecystectomy:

1. Males and Females between the ages of 18 -75
2. Diagnosis of gallstone disease that require cholecystectomy
3. ASA classification I
4. Mentally competent to give informed consent.
5. Scheduled to undergo a transgastric NOTES cholecystectomy.

Exclusion criteria for Group #2 transgastric cholecystectomy:

1. Pregnant women
2. Patients with a Body mass index > 35
3. Patients who are taking immunosuppressive medications or are immunocompromised
4. Patients who are on Proton Pump Inhibitors (PPI)
5. Patients with suspicion of gallbladder cancer
6. Patients with a history of open abdominal surgery
7. Patients with known common bile duct stones (gallstones are not limited to the gallbladder)
8. Patients on blood thinners or aspirin

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Group #1 NOTES Appendectomy - Transgastric approach

2

Group #2 NOTES Cholecystectomy - Transgastric approach

Interventions

Transgastric Appendectomy

The appendix will be removed through an incision in the stomach and pulled out through the mouth

Transgastric Cholecystectomy

The gallbladder will be removed through an incision in the stomach and pulled out through the mouth.

Primary outcome measure

  • To evaluate the safety and efficacy of transgastric NOTES appendectomies and cholecystectomies (through data collection). [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Sarah Lazar, MPH

619-471-0447misresearch@ucsd.edu

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92103

Principal Investigator:

Santiago Horgan, MD

More Information

Sponsor

University of California, San Diego

Last update posted

May 1, 2018

Last verified

Apr, 2018

Keywords

  • appendicitis
  • cholelithiasis
  • gallstones

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2018-05-01.