About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age >= 18 years
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)
Indication for elective benign gynecological surgery
Signed written informed consent for data collection
Disqualifiers
Age < 18 years
Suspected or confirmed malignant gynecological disease
Current pregnancy
Emergency / unscheduled surgical procedure
Trial population
Women scheduled to undergo elective surgery for benign gynecological conditions (including uterine fibroids, adenomyosis, endometriosis, pelvic growths, pelvic adhesions, cervical-vulvar-vaginal dysplasia, endometrial hyperplasia, infertility, pelvic inflammatory disease, intracavitary polyps/myomas, female genital malformations, or genital prolapse) at the Gynecology Unit of IRCCS San Raffaele Hospital.
Trial design
Cohort
Prospective
Treatments tested in this trial
Standard Surgical Procedures for Benign Gynecological Conditions
Procedure/SurgeryPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
Intraoperative and Postoperative Complications
Incidence and severity of intraoperative and postoperative complications categorized according to the Clavien-Dindo classification
Secondary outcomes
Operative Time
Total duration of the surgical procedure measured from skin incision to skin closure, reported in minutes
Surgical Blood Loss
Estimated total intraoperative blood loss measured in milliliters (mL)
Length of Hospital Stay
Total duration of hospitalization from admission for surgery to hospital discharge, reported in days
Post-operative Pain Score
Post-operative pain level assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain severity
Sponsors and contacts
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