AAGL 2021 Classification and Surgical Complications in Women With Endometriosis

NCT06825442 | Not Yet Recruiting

• 1 other identifier: ENDOCHIR
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis

Keywords

endometriosis; surgery; surgical complications; AAGL Classification 2021

Outcome Measures

Primary Outcomes (1)

• Association between AAGL staging and the occurrence of peri-operative complications

  Occurrence of (one or more) peri-operative complications

  within 90 days from surgery

Secondary Outcomes (6)

• Association between the AAGL score, ENZIAN classification, r-ASRM stage and the occurrence of peri-operative complications

  within 90 days from surgery

• Occurrence of peri-operative complications in patients undergoing surgery for DIE compared to patients undergoing surgery for DIE with hysterectomy

  within 90 days from surgery

• Occurrence of peri-operative complications in patients who underwent preoperative medical therapy compared to patients who did not

  within 90 days from surgery

• Occurrence of peri-operative complications in patients who underwent peri-operative medical therapy compared to patients who discontinued medical therapy close to surgery

  within 90 days from surgery

• Occurrence of clinical/radiological recurrence of disease at 24 months in patients who underwent peri-operative medical therapy compared to patients who discontinued medical therapy close to surgery

  24 months after surgery

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women of childbearing age with endometriosis undergoing complete laparoscopic removal of endometriotic lesions between January 2018 and December 2023 consecutively

You may qualify if:

• 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

You may not qualify if:

• Gynaecological oncology;
• Incomplete resection of macroscopic endometriotic lesions

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Diego Raimondo, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Raimondo, MD

CONTACT

+393290636618; die.raimondo@gmail.com

Pierluigi Celerino, MD

CONTACT

celerinopierluigi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 13, 2025
• Study Start: February 1, 2025
• Primary Completion: March 2, 2025
• Study Completion: May 2, 2025
• Last Updated: February 13, 2025

Record last verified: 2024-11

Locations

IT (1)