AppendicitisNCT00806429
Transvaginal Appendectomy
A study testing transvaginal appendectomy in people with Appendicitis, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility and safety of transvaginal appendectomy and determine and compare the postoperative pain and quality of life after surgery to standard laparoscopic transabdominal appendectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Appendicitis
- What is being tested?
- transvaginal appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2011
- Phase
- Interventional
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ultrasound or CT-based diagnosis of acute or chronic appendicitis
- ASA classification 1 or 2
Who cannot join
- BMI >35
- on Immunosuppressive meds or immunocompromised
- on blood thinners or aspirin or abnormal coagulation tests
- h/o ectopic pregnancy, PID or endometriosis
- prior open abdominal surgery or transvaginal surgery
- with diffuse peritonitis
Show all 9Show fewer
- evidence of abscess
- retroflexed uterus
- non english speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Hospital
New Haven, Connecticut, 06510
About this study
The purpose of this study is to determine the feasibility and safety of transvaginal appendectomy and determine and compare the postoperative pain and quality of life after surgery to standard laparoscopic transabdominal appendectomy.
- Conditions
- Appendicitis
- Being tested
- transvaginal appendectomy
- Keywords
- appendicitis, surgery, laparoscopy, natural orifice transluminal surgery
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal appendectomyProcedure or surgery
patient undergoes transvaginal appendectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | transvaginal appendectomy Receives: Procedure: transvaginal appendectomy |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of transvaginal appendectomy
Measured: 1 year
Secondary outcomes (2)
pain
Measured: 1 year
quality of life
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 posted10 Dec 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kurt E Roberts, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806429
- Sponsor's protocol ID
- 0712003306
- Status last verified
- Jan 2012
- First submitted
- 2 Dec 2008
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Roberts KE, Solomon D, Mirensky T, Silasi DA, Duffy AJ, Rutherford T, Longo WE, Bell RL. Pure transvaginal appendectomy versus traditional laparoscopic appendectomy for acute appendicitis: a prospective cohort study. Ann Surg. 2012 Feb;255(2):266-9. doi: 10.1097/SLA.0b013e31823b2748.
PubMed 22167005
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Appendectomy
- ClinicalTrials.gov ID
- NCT00806429
- Acronym / sponsor ID
- 0712003306
- Conditions
- Appendicitis
- Keywords
- appendicitis, surgery, laparoscopy, natural orifice transluminal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Dec 2008 (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.
The purpose of this study is to determine the feasibility and safety of transvaginal appendectomy and determine and compare the postoperative pain and quality of life after surgery to standard laparoscopic transabdominal appendectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: transvaginal appendectomytransvaginal appendectomy |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ultrasound or CT-based diagnosis of acute or chronic appendicitis
- ASA classification 1 or 2
Key exclusion criteria (9 listed)
- BMI >35
- on Immunosuppressive meds or immunocompromised
- on blood thinners or aspirin or abnormal coagulation tests
- h/o ectopic pregnancy, PID or endometriosis
- prior open abdominal surgery or transvaginal surgery
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 appendectomypatient undergoes transvaginal appendectomy | Procedure or surgery | 1 |
Primary outcome
feasibility of transvaginal appendectomy
Time frame: 1 year
2 secondary outcomes
pain
Time frame: 1 year
quality of life
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 17 Oct 2017.
- Derived from this study: PubMed 22167005Roberts KE, Solomon D, Mirensky T, Silasi DA, Duffy AJ, Rutherford T, Longo WE, Bell RL. Pure transvaginal appendectomy versus traditional laparoscopic appendectomy for acute appendicitis: a prospective cohort study. Ann Surg. 2012 Feb;255(2):266-9. doi: 10.1097/SLA.0b013e31823b2748.
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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.
Kurt E Roberts, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transvaginal appendectomy in people with Appendicitis, run by Yale University 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 2 inclusion and 9 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 17 Oct 2017. 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?
feasibility of transvaginal appendectomy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00806429, which also lists 1 linked publication.
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 17 Oct 2017.