Endometriosis of the AppendixNCT01921634
Endometriosis and the Appendix - Incidence and Pathologic Analysis
A study testing Modified Pathologic Analysis in people with Endometriosis of the Appendix, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
There is great variation seen in the incidence of appendiceal endometriosis. The variation is most likely multifactorial, but method with which the specimen is examined may play a role. If analysis using more cuts is used, appendiceal endometriosis may be diagnosed at a higher rate. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Endometriosis of the Appendix
- What is being tested?
- Modified Pathologic Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- English Speaking
- Women age 18-51 years of age
- Chronic pelvic pain and/or diagnosis of endometriosis
- Appendix removed at time of laparoscopy for treatment of endometriosis and/or pelvic pain
Who cannot join
- Non-English speaking
- Previous appendectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
About this study
Official title: Endometriosis and the Appendix: Is Incidence Related to Method of Pathologic Analysis?
There is great variation seen in the incidence of appendiceal endometriosis. The variation is most likely multifactorial, but method with which the specimen is examined may play a role. If analysis using more cuts is used, appendiceal endometriosis may be diagnosed at a higher rate.
Read the detailed description
Endometriosis is the presence of endometrial and stromal glands at extrauterine sites. One of the extrauterine sites that may be involved is the GI tract. The extent of bowel involvement can range from an incidental spot on the serosa to ectopic endometrium causing a bowel obstruction. The rate at which the bowel is involved ranges from 3-34%, as noted by Gustofson in a literature review published in Fertility and Sterility. The symptomatology of GI endometriosis can be vast. Presenting as cyclic or chronic pelvic pain, right lower quadrant pain, melena, GI upset/pain, and as serious as intussusception and appendicitis.
The incidence with which endometriosis is identified in the appendix potentially causing the complications that were noted, is reported as a wide range, 1-22%. The low of 1% is reported in two separate studies. The first, by Harper and Soules, published in the International Journal of Gynecology and Obstetrics, and the second, by Weed and Ray, in Obstetrics and Gynecology. The highest rate of 22% was reported by Berker and colleagues in the Journal of Minimally Invasive Gynecology. Noting the possibility of greater than 20% of individuals with endometriosis having appendiceal involvement, incidental appendectomy may be of benefit.
The American College of Obstetrics and Gynecology (ACOG) released a Committee Opinion on incidental appendectomy that was reaffirmed in 2012. These are the guidelines that are followed by gynecologists today. ACOG notes that women 35years of age and younger benefit the most from elective coincidental appendectomy. Others who may be of significant benefit are those patients with a complicated differential, those in who chemotherapy is anticipated, and those who are expected to have extensive post-op adhesions.
ACOG goes on to note that the decision to perform an appendectomy at the time of a gynecologic procedure should be based on individual scenarios after the risks and benefits are discussed with the patient. The procedure has a low risk of morbidity, and if there is reasonable probability the benefits outweigh the risks, based on age or history, elective coincidental appendectomy during primary gynecologic procedure may be appropriate.
Considering the variation seen in publications, the rate of diagnosis that the surgeon may find may be broad. The reason for this variation, though, is under speculation. Although, it is most likely multifactorial, the method with which the specimen is analyzed may play a role. In all of the methods sections in the above mentioned research papers and others regarding this topic, description of the technique used for pathologic analysis was not available. Here at Penn State Hershey Medical Center, a 3 slice method is employed. A cut is made at the proximal and distal end, and a third cut in the center. If this method is modified to include more cuts, the hypothesis is that endometriosis of the appendix will be diagnosed at a higher rate. Appendix specimens will be collected as indicated, following ACOG recommendations. After removal of the appendix patient's will be consented to allow the second pathologic analysis. Time frame for collection and second analysis will be approximately 12 months, the anticipated time to obtain 100 specimens.
- Conditions
- Endometriosis of the Appendix
- Being tested
- Modified Pathologic Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Pathologic AnalysisOther
| Study group | Role | What they receive |
|---|---|---|
| Standard analysis | Other | Standard pathological analysis currently used. Receives: Other: Modified Pathologic Analysis |
| Modified Pathologic Analysis | Other | After undergoing standard pathologic analysis, each specimen will then undergo the modified pathologic analysis. Receives: Other: Modified Pathologic Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Endometriosis of the Appendix
Post-operatively, the proposed second analysis of the appendix, the experimental/investigative portion, will be discussed with the patient in complete detail. If the patient is agreeable, consent will be signed post-operatively. The time from decision to perform two pathologic analysis/consent signing, to the time the pathologic diagnosis is made is anticipated to be approximately 1 week, as this is custom time frame for most pathologic final diagnosis, but up to 6 months, whichever comes first.
Data will be analyzed to determine if there is a significant difference in the diagnosis when comparing the standard pathologic analysis to the modified pathologic analysis.
Data will be collected for approximately one year, which is the time anticipated to collect 100 specimens.
Measured: From time of consent signing for participation in this study to the final pathologic tissue diagnosis, anticipated to be 1 week for final diagnosis or up to 6 months, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometriosis of the AppendixStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Benton, MD, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921634
- Sponsor's protocol ID
- 042383EP
- Status last verified
- Sep 2020
- First submitted
- 6 Aug 2013
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometriosis and the Appendix: Is Incidence Related to Method of Pathologic Analysis?
- ClinicalTrials.gov ID
- NCT01921634
- Acronym / sponsor ID
- 042383EP
- Conditions
- Endometriosis of the Appendix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is great variation seen in the incidence of appendiceal endometriosis. The variation is most likely multifactorial, but method with which the specimen is examined may play a role. If analysis using more cuts is used, appendiceal endometriosis may be diagnosed at a higher rate.
Detailed description
Endometriosis is the presence of endometrial and stromal glands at extrauterine sites. One of the extrauterine sites that may be involved is the GI tract. The extent of bowel involvement can range from an incidental spot on the serosa to ectopic endometrium causing a bowel obstruction. The rate at which the bowel is involved ranges from 3-34%, as noted by Gustofson in a literature review published in Fertility and Sterility. The symptomatology of GI endometriosis can be vast. Presenting as cyclic or chronic pelvic pain, right lower quadrant pain, melena, GI upset/pain, and as serious as intussusception and appendicitis.
The incidence with which endometriosis is identified in the appendix potentially causing the complications that were noted, is reported as a wide range, 1-22%. The low of 1% is reported in two separate studies. The first, by Harper and Soules, published in the International Journal of Gynecology and Obstetrics, and the second, by Weed and Ray, in Obstetrics and Gynecology. The highest rate of 22% was reported by Berker and colleagues in the Journal of Minimally Invasive Gynecology. Noting the possibility of greater than 20% of individuals with endometriosis having appendiceal involvement, incidental appendectomy may be of benefit.
The American College of Obstetrics and Gynecology (ACOG) released a Committee Opinion on incidental appendectomy that was reaffirmed in 2012. These are the guidelines that are followed by gynecologists today. ACOG notes that women 35years of age and younger benefit the most from elective coincidental appendectomy. Others who may be of significant benefit are those patients with a complicated differential, those in who chemotherapy is anticipated, and those who are expected to have extensive post-op adhesions.
ACOG goes on to note that the decision to perform an appendectomy at the time of a gynecologic procedure should be based on individual scenarios after the risks and benefits are discussed with the patient. The procedure has a low risk of morbidity, and if there is reasonable probability the benefits outweigh the risks, based on age or history, elective coincidental appendectomy during primary gynecologic procedure may be appropriate.
Considering the variation seen in publications, the rate of diagnosis that the surgeon may find may be broad. The reason for this variation, though, is under speculation. Although, it is most likely multifactorial, the method with which the specimen is analyzed may play a role. In all of the methods sections in the above mentioned research papers and others regarding this topic, description of the technique used for pathologic analysis was not available. Here at Penn State Hershey Medical Center, a 3 slice method is employed. A cut is made at the proximal and distal end, and a third cut in the center. If this method is modified to include more cuts, the hypothesis is that endometriosis of the appendix will be diagnosed at a higher rate. Appendix specimens will be collected as indicated, following ACOG recommendations. After removal of the appendix patient's will be consented to allow the second pathologic analysis. Time frame for collection and second analysis will be approximately 12 months, the anticipated time to obtain 100 specimens.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard analysis | Other | Other: Modified Pathologic AnalysisStandard pathological analysis currently used. |
| Modified Pathologic Analysis | Other | Other: Modified Pathologic AnalysisAfter undergoing standard pathologic analysis, each specimen will then undergo the modified pathologic analysis. |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- English Speaking
- Women age 18-51 years of age
- Chronic pelvic pain and/or diagnosis of endometriosis
- Appendix removed at time of laparoscopy for treatment of endometriosis and/or pelvic pain
Key exclusion criteria (2 listed)
- Non-English speaking
- Previous appendectomy
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 |
|---|---|---|
| Modified Pathologic Analysis | Other | Modified Pathologic Analysis, Standard analysis |
Primary outcome
Incidence of Endometriosis of the Appendix
Time frame: From time of consent signing for participation in this study to the final pathologic tissue diagnosis, anticipated to be 1 week for final diagnosis or up to 6 months, whichever comes first
Post-operatively, the proposed second analysis of the appendix, the experimental/investigative portion, will be discussed with the patient in complete detail. If the patient is agreeable, consent will be signed post-operatively. The time from decision to perform two pathologic analysis/consent signing, to the time the pathologic diagnosis is made is anticipated to be approximately 1 week, as this is custom time frame for most pathologic final diagnosis, but up to 6 months, whichever comes first. Data will be analyzed to determine if there is a significant difference in the diagnosis when comparing the standard pathologic analysis to the modified pathologic analysis. Data will be collected for approximately one year, which is the time anticipated to collect 100 specimens.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Pathologic Analysis in people with Endometriosis of the Appendix, run by Milton S. Hershey Medical Center 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 4 inclusion and 2 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 19 Oct 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?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Endometriosis of the Appendix (time frame: From time of consent signing for participation in this study to the final pathologic tissue diagnosis, anticipated to be 1 week for final diagnosis or up to 6 months, whichever comes first). 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 19 Oct 2020.