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

Appendicitis Clinical Trial

— NOTES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00531219
• Other study ID #: 071114, 140016
• Status: Recruiting
• Start date: February 2008
• Est. completion date: February 2020

Study information

• Verified date: April 2018
• Source: University of California, San Diego
• Contact: Sarah Lazar, MPH
• Phone: 619-471-0447
• Email: misresearch[@]ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and efficacy of transgastric NOTES appendectomies and cholecystectomies (through data collection).		1 year
Secondary	To evaluate pain associated with the transgastric approach (through data collection).		1 year