Trial Outcomes & Findings for Endometriosis and the Appendix - Incidence and Pathologic Analysis (NCT NCT01921634)
NCT ID: NCT01921634
Last Updated: 2020-10-19
Results Overview
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.
COMPLETED
NA
300 participants
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
2020-10-19
Participant Flow
Participant milestones
| Measure |
Women Undergoing Appendectomy
Women undergoing coincidental appendectomy at time of primary gynecological procedure
|
|---|---|
|
Overall Study
STARTED
|
300
|
|
Overall Study
COMPLETED
|
300
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endometriosis and the Appendix - Incidence and Pathologic Analysis
Baseline characteristics by cohort
| Measure |
Women Undergoing Appendectomy
n=300 Participants
Women undergoing coincidental appendectomy at time of primary gynecological procedure
|
|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 6.8 • n=39 Participants
|
|
Sex: Female, Male
Female
|
300 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
BMI
|
28.7 kg/m2
STANDARD_DEVIATION 7.0 • n=39 Participants
|
PRIMARY outcome
Timeframe: 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 firstPopulation: Each subject's specimen underwent standard pathological analysis followed by modified pathologic analysis.
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.
Outcome measures
| Measure |
Standard Analysis
n=300 Participants
Standard pathological analysis currently used.
|
Modified Pathologic Analysis
n=300 Participants
After undergoing standard pathologic analysis, each specimen undergoes the modified pathologic analysis.
|
|---|---|---|
|
Incidence of Endometriosis of the Appendix
|
23 Participants
|
30 Participants
|
Adverse Events
Women Undergoing Appendectomy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Andrea Benton, MD
The Pennsylvania State University, Hershey Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place