Trial record 18 of 75 for:    Open Studies | "Gallbladder Diseases"

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

This study is currently recruiting participants.
Verified July 2011 by University of California, San Diego
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00531219
First received: September 17, 2007
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

A research study to find out more about an investigational approach to perform surgery that has not been done in humans before at this institution. Normally this type of surgery would be done laparoscopically or open. Laparoscopic surgery is where the doctor would make several (3-6) small openings in the abdomen; place a camera and other instruments, and remove the gallbladder through a small incision in the lower right abdomen. Open surgery is where the doctor makes approximately a 6 inch incision into the abdomen and removes the gallbladder. This investigational procedure is called Natural Orifice Translumenal Endoscopic Surgery (NOTES). This means that surgery would be done through the mouth, vagina or rectum. In this study, the doctor would like to perform this investigational method of surgery through the mouth.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 assess the safety and efficacy of a novel approach to minimally invasive surgical techniques [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess pain associated with transgastric approach [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: February 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Group 2: Transgastric Cholecystectomy
Procedure: Transgastric Cholecystectomy
The gallbladder will be removed through an incision in the stomach and pulled out through the mouth.
Active Comparator: 1
Group 1: Transgastric laparoscopic assisted appendectomy
Procedure: Transgastric Appendectomy
The appendix will be removed through an incision in the stomach and pulled out through the mouth

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria for the Group #1 transgastric appendectomy:

  1. Males and females between the ages of 18-65
  2. Clinical diagnosis of appendicitis emergency room evaluation within 36 hours of the onset of pain
  3. ASA classification I

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 with severe medical comorbidities who not ASA class I or II will be excluded
  5. Patients who are on proton pump inhibitors (PPI)
  6. Patients with evidence of an abdominal abscess or mass on CT scan
  7. Patients who present with a clinical diagnosis of sepsis
  8. Patients who have a history of open abdominal surgery
  9. Patients with diffuse peritonitis on clinical examination
  10. Patients on blood thinners, aspirin, or patients with other coagulation abnormalities

Inclusion criteria for Group #2 transgastric cholecystectomy:

  1. Males and females between the ages of 18 -65
  2. Diagnosis of gallstone disease that require cholecystectomy
  3. ASA classification I

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 with severe medical comorbidities
  5. Patients who are on proton pump inhibitors (PPI)
  6. Patients with suspicion of gallbladder cancer
  7. Patients with a history of open abdominal surgery
  8. Patients with known common bile duct stones (gallstones are not limited to the gallbladder)
  9. Patients on blood thinners or aspirin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531219

Contacts
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu
Contact: Cece Echon, RN, MSN 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
Study Chair: Mark A Talamini, MD University of California, San Diego
  More Information

No publications provided

Responsible Party: Santiago Horgan, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00531219     History of Changes
Other Study ID Numbers: 071114
Study First Received: September 17, 2007
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Gallbladder Diseases
Appendicitis
Acute Disease
Cholelithiasis
Cholecystolithiasis
Gallstones
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Biliary Tract Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014