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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Santiago Horgan, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00531219
First received: September 17, 2007
Last updated: March 26, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention
Appendicitis
Cholelithiasis
Procedure: Transgastric Appendectomy
Procedure: Transgastric Cholecystectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transgastric Appendectomy and Cholecystectomy

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • To evaluate the safety and efficacy of transgastric NOTES appendectomies and cholecystectomies (through data collection). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate pain associated with the transgastric approach (through data collection). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2008
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531219

Contacts
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Principal Investigator: Santiago Horgan, MD         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Santiago Horgan, MD University of California, San Diego
  More Information

No publications provided

Responsible Party: Santiago Horgan, Professor of Surgery, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00531219     History of Changes
Other Study ID Numbers: 071114, 140016
Study First Received: September 17, 2007
Last Updated: March 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
appendicitis
cholelithiasis
gallstones

Additional relevant MeSH terms:
Appendicitis
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Calculi
Cecal Diseases
Digestive System Diseases
Gallbladder Diseases
Gastroenteritis
Gastrointestinal Diseases
Infection
Intestinal Diseases
Intraabdominal Infections
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 29, 2015