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

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

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.

Study Overview

• Status: Unknown
• Conditions: Appendicitis; Cholelithiasis
• Intervention / Treatment: Procedure: Transgastric Appendectomy; Procedure: Transgastric Cholecystectomy

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • Recruiting
      • University of California, San Diego
      • Principal Investigator: Santiago Horgan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

There will be 2 groups in this study: Of special note, the inclusion criteria clearly states subjects must be seen within 36 hours of the onset of pain and have an ASA Classification of I. This is intended to avoid obtaining informed consent from a subject who is in severe pain and incapable of making an informed decision, as well as avoid coercion. An ASA Classification of I defines a healthy normal individual.

1. Group 1 will be transgastric laparoscopic assisted appendectomy
2. Group 2 will be transgastric laparoscopic assisted cholecystectomy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Group #1 NOTES Appendectomy - Transgastric approach	Procedure: Transgastric Appendectomy; The appendix will be removed through an incision in the stomach and pulled out through the mouth
2; Group #2 NOTES Cholecystectomy - Transgastric approach	Procedure: Transgastric Cholecystectomy; The gallbladder will be removed through an incision in the stomach and pulled out through the mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the safety and efficacy of transgastric NOTES appendectomies and cholecystectomies (through data collection).	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate pain associated with the transgastric approach (through data collection).	1 year

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: September 17, 2007
• First Submitted That Met QC Criteria: September 17, 2007
• First Posted (Estimate): September 18, 2007

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: appendicitis; gallstones; cholelithiasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Cecal Diseases; Intraabdominal Infections; Calculi; Appendicitis; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: 071114, 140016