IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Location contact
Diego Raimondo, MD
CONTACT
Diego Raimondo, MD
PRINCIPAL_INVESTIGATOR
Pierluigi Celerino, MD
CONTACT
NCT Number: NCT06825442
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.
Trial opening soon.
Get Notified18 year–55 year
Female
Observational
Bologna, 40138, Italy
Diego Raimondo, MD
CONTACT
Diego Raimondo, MD
PRINCIPAL_INVESTIGATOR
Pierluigi Celerino, MD
CONTACT
Endometriosis is a benign chronic inflammatory disease associated with pelvic pain and subfertility, characterised by endometrial tissue located outside the uterus. Deep endometriosis (deep infiltrating endometriosis, DIE), the most severe form of endometriosis, can be defined as the involvement of anatomical organs and tissues by endometriotic lesions, regardless of the depth of infiltration.
The first therapeutic approach for deep endometriosis is hormone therapy; surgery should be limited to patients who have not responded or have intolerance to medical therapy, infertile patients with failed attempts at assisted reproductive technologies, or patients with critical ureteral or intestinal stenosis. Although complete removal of the disease has proven effective in reducing pain and improving fertility results, surgical complications can occur in 3% to 22% of cases and can drastically reduce patients' quality of life.
Several intraoperative staging systems for endometriosis have been proposed. However, there is a lack of a scoring system that accurately describes the disease burden. Recently, the American Association of Gynecologic Laparoscopists (AAGL) has developed and validated an anatomy-based grading system for intraoperative scoring of surgical complexity, using a qualitative index scale as a reference that identifies a score and also allows the assignment of a surgical complexity stage.
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 imperative 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 operated patients but also to identify preoperatively those DIE pictures for which the surgeon will have to pay more attention because they have a higher risk of perioperative adverse events.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: within 90 days from surgery
Occurrence of (one or more) peri-operative complications
Time frame: within 90 days from surgery
Occurrence of (one or more) peri-operative complications
Time frame: within 90 days from surgery
Occurrence of (one or more) peri-operative complications
Time frame: within 90 days from surgery
Occurrence of (one or more) peri-operative complications
Time frame: within 90 days from surgery
Occurrence of (one or more) peri-operative complications
Time frame: 24 months after surgery
Onset of disease recurrence
Time frame: At 3, 6, 9, 12, 24 and 36 months after surgery
Onset of pregnancy
Contact information is provided by the study sponsor or research team.
Diego Raimondo, MD
CONTACT
Pierluigi Celerino, MD
CONTACT
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
AAGL 2021 Classification System And Risk Of Surgical Complications In Women Undergoing Surgery For Endometriosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07664956
Abnormal Uterine Bleeding, Unspecified, Adenomyosis
Newark, Delaware, United States
View Trial DetailsNCT07652593
Endometriosis, Female Urogenital Diseases
Suresnes, France
View Trial DetailsNCT07645196
Dysmenorrhea, Endometriosis
Brussels, Brussels Capital, Belgium
View Trial DetailsNCT07635199
Endometriosis, Female Urogenital Diseases
View Trial Details