NCT06825442Not yet recruiting
AAGL 2021 Classification and Surgical Complications in Women With Endometriosis
AAGL 2021 Classification System And Risk Of Surgical Complications In Women Undergoing Surgery For Endometriosis
Source: ClinicalTrials.gov · Last updated 13 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Several classifications exist to describe peri-operative complications including the Clavien-Dindo classification which is easily applicable to laparoscopic removal of endometriosis in all stages and is widely recommended for the evaluation of outcomes of endometriosis surgery. The most widely used staging system is the one reviewed by the American Society of Reproductive Medicine (rASRM) which, however, does not study DIE. In contrast, the ENZIAN score studies the anterior, posterior and lateral compartment of the pelvis and provides more reliable information on the extent of lesions. On the other hand, the rASRM and ENZIAN classification systems expressing the disease burden only indirectly correlate with the risk of postoperative complications and are not good predictors of post-surgical complications \[19\]. There are no studies in the literature evaluating the association of these complications with aspects such as the technical difficulty of surgical removal of endometriosis in relation to the extent of the disease. The study of perioperative complications is essential in endometriosis surgery, so having a classification system capable of predicting complications on the basis of surgical complexity could guide clinical practice and post-operative management of patients with DIE. This study could provide useful elements not only to improve the post-operative outcome of the operated patients, but also to identify preoperatively those pictures of DIE for which the surgeon will have to pay more attention because they have a higher risk of perioperative adverse events.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 198 (estimated)
- First submitted
- 10 Jan 2025
- Start date
- Feb 2025
- Primary completion date
- 2 Mar 2025
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Diseases
- Endometriosis
- NCT number
- NCT06825442
What you commit to
- Study type: Observational
- Planned participants: 198
- From Feb 2025 to the primary completion date, 2 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Incomplete resection of macroscopic endometriotic lesions
Other
- Gynaecological oncology;
Who the study is looking for
- 18 years to 55 years;
- Pelvic ultrasound and/or radiological (MRI/ CT scan with rectal insufflation) diagnosis of endometriosis and surgery;
- At least 90 days of follow-up after surgery;
- Acquisition of informed consent for participation in the study and processing of data
Age in the registry: 18 years to 55 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.