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Endometriosis and the Appendix - Incidence and Pathologic Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01921634
Recruitment Status : Completed
First Posted : August 13, 2013
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Andrea Benton, MD, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE August 6, 2013
First Posted Date  ICMJE August 13, 2013
Results First Submitted Date  ICMJE September 22, 2020
Results First Posted Date  ICMJE October 19, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE August 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
Incidence of Endemetriosis 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endometriosis and the Appendix - Incidence and Pathologic Analysis
Official Title  ICMJE Endometriosis and the Appendix: Is Incidence Related to Method of Pathologic Analysis?
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Condition  ICMJE Endometriosis of the Appendix
Intervention  ICMJE Other: Modified Pathologic Analysis
Study Arms  ICMJE
  • Standard analysis
    Standard pathological analysis currently used.
    Intervention: Other: Modified Pathologic Analysis
  • Modified Pathologic Analysis
    After undergoing standard pathologic analysis, each specimen will then undergo the modified pathologic analysis.
    Intervention: Other: Modified Pathologic Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2020)
300
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2013)
100
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Non-English speaking
  • Previous appendectomy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 51 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01921634
Other Study ID Numbers  ICMJE 042383EP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrea Benton, MD, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Milton S. Hershey Medical Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP