AppendicitisNOTESNCT00531219
Minimally Invasive Surgery: Using Natural Orifice Translumenal Endoscopic Surgery (NOTES)
An observational study of Appendicitis and Cholelithiasis, run by University of California, San Diego at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Appendicitis, Cholelithiasis
- What is being tested?
- Transgastric Appendectomy and Transgastric Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
None listed.
Who cannot join
- Pregnant women
- Morbidly obese patients (Body mass index > 35)
- Patients who are taking immunosuppressive medications or are immunocompromised
- Patients who are on Proton Pump Inhibitors (PPI)
- Patients with evidence of an abdominal abscess or mass on CT scan
- Patients who present with a clinical diagnosis of sepsis
Show all 24Show fewer
- Patients who have a history of open abdominal surgery
- Patients with diffuse peritonitis
- Patients on blood thinners or aspirin
- Inclusion criteria for Group #2 transgastric cholecystectomy:
- Males and Females between the ages of 18 -75
- Diagnosis of gallstone disease that require cholecystectomy
- ASA classification I
- Mentally competent to give informed consent.
- Scheduled to undergo a transgastric NOTES cholecystectomy.
- Exclusion criteria for Group #2 transgastric cholecystectomy:
- Pregnant women
- Patients with a Body mass index > 35
- Patients who are taking immunosuppressive medications or are immunocompromised
- Patients who are on Proton Pump Inhibitors (PPI)
- Patients with suspicion of gallbladder cancer
- Patients with a history of open abdominal surgery
- Patients with known common bile duct stones (gallstones are not limited to the gallbladder)
- Patients on blood thinners or aspirin
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
San Diego, California, 92103
Santiago Horgan, MD
About this study
Official title: 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.
- Conditions
- Appendicitis, Cholelithiasis
- Being tested
- Transgastric Appendectomy, Transgastric Cholecystectomy
- Keywords
- appendicitis, cholelithiasis, gallstones
- Medical subject headings
- Appendicitis, Cholelithiasis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transgastric AppendectomyProcedure or surgery
The appendix will be removed through an incision in the stomach and pulled out through the mouth
Transgastric CholecystectomyProcedure or surgery
The gallbladder will be removed through an incision in the stomach and pulled out through the mouth.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Group #1 NOTES Appendectomy - Transgastric approach Receives: Procedure: Transgastric Appendectomy | |
| 2 | Group #2 NOTES Cholecystectomy - Transgastric approach Receives: Procedure: Transgastric Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and efficacy of transgastric NOTES appendectomies and cholecystectomies (through data collection).
Measured: 1 year
Secondary outcomes (1)
To evaluate pain associated with the transgastric approach (through data collection).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startFeb 2008
- Primary completionDec 2018 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago Horgan, University of California, San Diego
- Investigators
- Santiago Horgan, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531219
- Sponsor's protocol ID
- 071114, 140016
- Acronym
- NOTES
- Status last verified
- Apr 2018
- First submitted
- 17 Sep 2007
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transgastric Appendectomy and Cholecystectomy
- ClinicalTrials.gov ID
- NCT00531219
- Acronym / sponsor ID
- NOTES / 071114, 140016
- Conditions
- Appendicitis, Cholelithiasis
- Keywords
- appendicitis, cholelithiasis, gallstones
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 18 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Transgastric AppendectomyGroup #1 NOTES Appendectomy - Transgastric approach |
| 2 | – | Procedure: Transgastric CholecystectomyGroup #2 NOTES Cholecystectomy - Transgastric approach |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (24 listed)
- Pregnant women
- Morbidly obese patients (Body mass index > 35)
- Patients who are taking immunosuppressive medications or are immunocompromised
- Patients who are on Proton Pump Inhibitors (PPI)
- Patients with evidence of an abdominal abscess or mass on CT scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transgastric AppendectomyThe appendix will be removed through an incision in the stomach and pulled out through the mouth | Procedure or surgery | 1 |
| Transgastric CholecystectomyThe gallbladder will be removed through an incision in the stomach and pulled out through the mouth. | Procedure or surgery | 2 |
Primary outcome
To evaluate the safety and efficacy of transgastric NOTES appendectomies and cholecystectomies (through data collection).
Time frame: 1 year
1 secondary outcome
To evaluate pain associated with the transgastric approach (through data collection).
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Horgan, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis and Cholelithiasis, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Lazar, MPH (619-471-0447, misresearch@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and efficacy of transgastric NOTES appendectomies and cholecystectomies (through data collection). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.