AppendicitisNOTESNCT00530998
Minimally Invasive Surgery: Using Natural Orfices
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 females undergoing transvaginal NOTES removal of their appendix or gallbladder. Female subjects who elect to have a transvaginal 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, women only
- Conditions the study is for
- Appendicitis, Cholelithiasis, Gallstones
- What is being tested?
- Transvaginal Appendectomy and Transvaginal Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Group #1: NOTES Appendectomy - Transvaginal approach: Subjects will be female between the ages of 18-75 who present to the emergency room and are subsequently diagnosed with acute appendicitis. Following diagnosis, investigators will determine if the procedure can be completed via the transvaginal approach. If the patient satisfies the listed criteria then researchers will present study information and offer participation. Group # 2: NOTES Cholecystectomy - Transvaginal approach: Female subjects, between the ages of 18-75 who present in the UCSD surgery clinic for elective cholecystectomy will be offered participation in this study.
Who may be able to join
- Females between the ages of 18-75
- Clinical diagnosis of appendicitis
- Emergency room evaluation within 36 hours of the onset of pain
- ASA Classification 1
- Mentally competent to give informed consent
- Scheduled to undergo a transvaginal NOTES appendectomy.
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- Females between the ages of 18 and 75
- Diagnosis of gallstone disease which requires cholecystectomy
- ASA class 1
- Mentally competent to give informed consent
- Scheduled to undergo a transvaginal NOTES cholecystectomy
Who cannot join
- Pregnant women (need to have negative icon in ER)
- Morbidly obese patients (BMI >35)
- Patients who are taking immunosuppressive medications or are immunocompromised
- Patients with evidence of an abdominal abscess or mass
- Patients who present with a clinical diagnosis of sepsis or peritonitis
- Patients who have a history of prior transvaginal surgery. Patients with prior laparoscopic surgery will be included.
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- Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
- Patients with diffuse peritonitis on clinical exam
- Patients on blood thinners or aspirin or abnormal blood coagulation tests
- Pregnant women
- Morbidly obese patients (BMI > 35)
- Patients who are taking immunosuppressive medications and/or immunocompromised
- Patients with severe medical comorbidities will be excluded.
- Patients with a presumed gallbladder polyps, mass or tumor
- Patients with a history of prior transvaginal surgery. Patients with prior laparoscopic surgery will be included.
- Patients with a history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis
- Patients with known common bile duct stones
- Patients on blood thinners or aspirin or abnormal blood coagulation tests
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92103
About this study
Official title: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Appendectomy and Cholecystectomy
This is an observational study of pain and outcomes from females undergoing transvaginal NOTES removal of their appendix or gallbladder. Female subjects who elect to have a transvaginal 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 complete a standardized sexual function questionnaire (Female Sexual Function Index) prior to surgery and 6 months 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, Gallstones
- Being tested
- Transvaginal Appendectomy, Transvaginal 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.
Transvaginal AppendectomyProcedure or surgery
The appendix will be removed via an incision in the vagina.
Transvaginal CholecystectomyProcedure or surgery
The gallbladder will be removed via an incision in the vagina.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Group #1 NOTES Appendectomy - Transvaginal approach Receives: Procedure: Transvaginal Appendectomy | |
| 2 | Group #2 NOTES Cholecystectomy - Transvaginal approach Receives: Procedure: Transvaginal 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 transvaginal NOTES appendectomies and cholecystectomies (through data collection).
Measured: 1 year
Secondary outcomes (1)
To evaluate pain associated with the transvaginal 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 startSep 2007
- Primary completionSep 2019
- Study completionSep 2019
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.
- 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
- 120 participants (actual)
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
- NCT00530998
- Sponsor's protocol ID
- 071115, 140015
- Acronym
- NOTES
- Status last verified
- Mar 2020
- First submitted
- 17 Sep 2007
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Appendectomy and Cholecystectomy
- ClinicalTrials.gov ID
- NCT00530998
- Acronym / sponsor ID
- NOTES / 071115, 140015
- Conditions
- Appendicitis, Cholelithiasis, Gallstones
- Keywords
- appendicitis, cholelithiasis, Gallstones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- 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 females undergoing transvaginal NOTES removal of their appendix or gallbladder. Female subjects who elect to have a transvaginal 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 complete a standardized sexual function questionnaire (Female Sexual Function Index) prior to surgery and 6 months 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: Transvaginal AppendectomyGroup #1 NOTES Appendectomy - Transvaginal approach |
| 2 | – | Procedure: Transvaginal CholecystectomyGroup #2 NOTES Cholecystectomy - Transvaginal approach |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group #1: NOTES Appendectomy - Transvaginal approach: Subjects will be female between the ages of 18-75 who present to the emergency room and are subsequently diagnosed with acute appendicitis. Following diagnosis, investigators will determine if the procedure can be completed via the transvaginal approach. If the patient satisfies the listed criteria then researchers will present study information and offer participation. Group # 2: NOTES Cholecystectomy - Transvaginal approach: Female subjects, between the ages of 18-75 who present in the UCSD surgery clinic for elective cholecystectomy will be offered participation in this study.
Key inclusion criteria (11 listed)
- Females between the ages of 18-75
- Clinical diagnosis of appendicitis
- Emergency room evaluation within 36 hours of the onset of pain
- ASA Classification 1
- Mentally competent to give informed consent
Key exclusion criteria (18 listed)
- Pregnant women (need to have negative icon in ER)
- Morbidly obese patients (BMI >35)
- Patients who are taking immunosuppressive medications or are immunocompromised
- Patients with evidence of an abdominal abscess or mass
- Patients who present with a clinical diagnosis of sepsis or peritonitis
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 |
|---|---|---|
| Transvaginal AppendectomyThe appendix will be removed via an incision in the vagina. | Procedure or surgery | 1 |
| Transvaginal CholecystectomyThe gallbladder will be removed via an incision in the vagina. | Procedure or surgery | 2 |
Primary outcome
To evaluate the safety and efficacy of transvaginal NOTES appendectomies and cholecystectomies (through data collection).
Time frame: 1 year
1 secondary outcome
To evaluate pain associated with the transvaginal approach (through data collection).
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
Related trials for Appendicitis
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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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 11 inclusion and 18 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: finished, as of the sponsor's last update on 10 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and efficacy of transvaginal 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 10 Mar 2020.