Adenomyosis, Benign Gynecological Disease, Ectopic Pregnancy, Endometriosis, Ovarian Cyst Benign, Pelvic Adhesions, Polyp Endometrium, Salpingitis, Uterine Fibroids
Conditions
Keywords
Gynecological Surgery, Perioperative Data, Laparoscopy, uterine fibroids, endometriosis, Registry, Uterine Myoma, Pelvic Pain, Surgical Outcomes, Hysteroscopy, Laparotomy, Perioperative Care, Postoperative Complications, Real-World Evidence
Brief 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.
Detailed description
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.
Interventions
PROCEDUREStandard 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.
Sponsors
IRCCS San Raffaele
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative and Postoperative Complications | perioperatively/periprocedurally | Incidence and severity of intraoperative and postoperative complications categorized according to the Clavien-Dindo classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | perioperatively/periprocedurally | Total duration of the surgical procedure measured from skin incision to skin closure, reported in minutes |
| Surgical Blood Loss | perioperatively/periprocedurally | Estimated total intraoperative blood loss measured in milliliters (mL) |
| Length of Hospital Stay | up to 30 days | Total duration of hospitalization from admission for surgery to hospital discharge, reported in days |
| Post-operative Pain Score | perioperatively/periprocedurally | 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 |
Countries
Italy
Contacts
CONTACTMassimo Candiani, MD, Prof
CONTACTGiorgio Candotti, MD
Outcome results
None listed