Brief Summary

The goal of this study is to evaluate the impact of Ziiwg Endotest on patient management decisions before and after the test. The main questions it aims to answer are:

* Does the test reduce the intention and number of laparoscopies in women whose decision to undergo laparoscopy was made before the test result was obtained?
* Does the test change management decisions in women with no prior indication for diagnostic laparoscopy?

Study will compare the patient management decision before and after the test.

The acts and procedures performed as part of this research are :

* Aa saliva sampling (Ziwig Endotest) at inclusion
* A mutidisciplinary meeting post test (if applicable)
* Completion at inclusion and 6 month of a quality-of-life questionnaire (EHP-5)
* Completion at inclusion and 6 month of a VAS for pain
* Completion at inclusion and 6 month of a Likert satisfaction scale
* A test results Announcement consultation
* A visit at 6 months.

Conditions

• Endometriosis

Intervention / Treatment

• Diagnostic Test: Ziwig Endotest®

Primary Outcome Measures

• Change in the number of laparoscopies related to the test result in women whose decision to undergo laparoscopy was made in multidiscplinary meeting before the test result was obtained. MCID 20% (After 6 months visits)
  The criterion is estimated after the test result is known. Each of these criteria is estimated independently at 3 different times: 1. After knowledge of the test result, management decided by the physician who carried out the inclusion consultation or at the PCR. 2. At the end of the consultation, shared decision 3. At 6 months: by the adjudication committee: positive opinion A hierarchical sequential analysis will be carried out independently according to the following scheme: Sequence 1: decisional impact of the test on the management decision, if conclusive compared with MCID (main criterion) → sequence 2: decisional impact of the test on the medical decision shared with the patient, if conclusive compared with MCID → sequence 3: percentage of favorable adjudications, conclusive if higher than MCID (highest level of evidence of clinical utility)
• Changes in subject management related to Ziwig Endotest® result) in women with no prior indication for diagnostic laparoscopy. MCID 30%. (After 6 months visits)
  The criterion is estimated after the test result is known. Each of these criteria is estimated independently at 3 different times: 1. After knowledge of the test result, management decided by the physician who carried out the inclusion consultation or at the PCR. 2. At the end of the consultation, shared decision 3. At 6 months: by the adjudication committee: positive opinion A hierarchical sequential analysis will be carried out independently according to the following scheme: Sequence 1: decisional impact of the test on the management decision, if conclusive compared with MCID (main criterion) → sequence 2: decisional impact of the test on the medical decision shared with the patient, if conclusive compared with MCID → sequence 3: percentage of favorable adjudications, conclusive if higher than MCID (highest level of evidence of clinical utility)

Countries

France

Locations and Investigators

• CHU Lyon Sud, Pierre-Bénite, France