Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery

N/ANot Yet RecruitingNCT07772076

IRCCS San Raffaele6,000 enrolled

Overview

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.

Benign gynecological diseases frequently require surgical intervention via laparoscopy, laparotomy, vaginal, or robotic approaches. This single-center registry prospectively records baseline patient characteristics, surgical parameters, intraoperative complications, and postoperative outcomes up to 30 days post-surgery (with standard clinical follow-up up to 3 years). The collected data will enable descriptive and exploratory comparative evaluations to optimize perioperative care and surgical management.

Study Type

OBSERVATIONAL

Enrollment

6,000

Conditions

Benign Gynecological Disease Uterine Fibroids Endometriosis Adenomyosis Pelvic Adhesions Ovarian Cyst Benign

Interventions

Standard Surgical Procedures for Benign Gynecological ConditionsPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Operative Time

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

Time frame: perioperatively/periprocedurally

Surgical Blood Loss

Estimated total intraoperative blood loss measured in milliliters (mL)

Time frame: perioperatively/periprocedurally

Length of Hospital Stay

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

Time frame: up to 30 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

Time frame: perioperatively/periprocedurally

Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts