Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIRCCS San Raffaele

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard Surgical Procedures for Benign Gynecological Conditions

    Procedure/Surgery

    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.

Treatment groups

6,000 Participants
are divided into 1 treatment group
Group A: Gynecological Surgery Cohort1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative and Postoperative Complications

Incidence and severity of intraoperative and postoperative complications categorized according to the Clavien-Dindo classification

Time frame
perioperatively/periprocedurally

Secondary outcomes

1

Operative Time

Total duration of the surgical procedure measured from skin incision to skin closure, reported in minutes

Time frame
perioperatively/periprocedurally
2

Surgical Blood Loss

Estimated total intraoperative blood loss measured in milliliters (mL)

Time frame
perioperatively/periprocedurally
3

Length of Hospital Stay

Total duration of hospitalization from admission for surgery to hospital discharge, reported in days

Time frame
up to 30 days
4

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

Time frame
perioperatively/periprocedurally

Other outcomes

Sponsors and contacts

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