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Starting soon Observational

Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery

NCT07772076 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-09
Last updated
2026-08-19

Condition(s) studied

Benign Gynecological DiseaseUterine FibroidsEndometriosisAdenomyosisPelvic AdhesionsOvarian Cyst BenignSalpingitisPolyp EndometriumEctopic Pregnancy

Investigational drug(s) / intervention(s)

Standard Surgical Procedures for Benign Gynecological Conditions

Standard Surgical Procedures for Benign Gynecological Conditions: Patients undergo standard-of-care elective surgery for benign gynecological conditions according to routine clinical practice, including laparoscopy, laparotomy, vaginal surgery, robotic-assisted surgery, operative hysteroscopy, or vNOTES. The choice of procedure is determined solely by clinician judgment and standard medical indication. Data on surgical technique, intraoperative parameters, and perioperative outcomes are recorded prospectively.

Study summary

This prospective observational registry aims to systematically collect preoperative, intraoperative, and postoperative clinical data from patients undergoing surgery for benign gynecological conditions. The main goal is to evaluate clinical outcomes, surgical approaches, and complications in real-world clinical practice.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age \>= 18 years 2. Diagnosis of benign gynecological disease (e.g., uterine fibroids, endometriosis, pelvic neoplasm, endometrial polyp, endometrial hyperplasia, cervical dysplasia, pelvic adhesions, isthmocele, genital prolapse, adenomyosis, female genital malformations, pelvic inflammatory disease) 3. Indication for elective benign gynecological surgery 4. Signed written informed consent for data collection Exclusion Criteria: 1. Age \< 18 years 2. Suspected or confirmed malignant gynecological disease 3. Current pregnancy 4. Emergency / unscheduled surgical procedure 5. No indication for surgery 6. Refusal or inability to provide signed informed consent

Primary outcome measure(s)

  • Intraoperative and Postoperative Complications — perioperatively/periprocedurally
    Incidence and severity of intraoperative and postoperative complications categorized according to the Clavien-Dindo classification

Trial sites (1)

FacilityCityRegionStatus
IRCCS Ospedale San Raffaele - U.O. Ginecologia e Ostetricia Milan Milano
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07772076 on ClinicalTrials.gov ↗ ← All trials in Italy