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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02973854
Other study ID # 25996
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date September 10, 2020

Study information

Verified date September 2020
Source St. Louis University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients seen at the SLUCare Center for Endometriosis (including those with or without pain) undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.

Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum will be excised (removed).

After surgical excision has been performed, in order to provide standardized specimens for our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3 mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue will be sent to histology (SSM) for evaluation and classification as having endometriosis or not. For each patient in the study, blood will also be collected to look for markers for endometriosis.


Description:

The study is investigator-initiated, prospective, comparative study. Laparoscopic surgery for endometriosis on patients presenting with pain, infertility or both will be performed by the principal investigator at St. Mary's Hospital. We will be collecting preoperative, operative and postoperative follow-up data on all patients recruited for this study based on comprehensive preoperative questionnaires, which includes data collection on pain scores (by VAS scales) and standardized QOL scales, and the 6-12 month follow questionnaire. The surgical approach in the treatment of endometriosis is by excision only, so that all lesions (abnormal areas of peritoneum) are excised resulting in tissue specimens that are classified at a histologic level, which is the gold standard way to diagnose the presence of endometriosis.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date September 10, 2020
Est. primary completion date September 10, 2020
Accepts healthy volunteers No
Gender Female
Age group 13 Years to 55 Years
Eligibility Inclusion Criteria:

- Patients seen at the Center for Endometriosis (including those with or without pain) who are undergoing excision surgery.

- Patients who are undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.

- Completed a preoperative questionnaire

Exclusion Criteria:

- prior bilateral salpingo-oophorectomy

- post natural menopause

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States SSM St. Mary's Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary S1PR1 levels in PBLs with and without endometriosis. To determine if S1PR1 levels in PBLs can discriminate between patients with endometriosis and patients without endometriosis. At Surgery
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