An observational study in Benign Gynecological Disease, Uterine Fibroids and Endometriosis, sponsored by IRCCS San Raffaele. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by IRCCS San Raffaele · Observational
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.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 150 across 107 observational studies indexed under Leiomyoma.
Browse Leiomyoma studies →IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women with indication for elective benign gynecological surgery undergoing standard clinical surgical procedures (laparoscopy, laparotomy, vaginal, robotic, hysteroscopy, vNOTES).
Procedure: 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.
Intraoperative and Postoperative Complications
Incidence and severity of intraoperative and postoperative complications categorized according to the Clavien-Dindo classification
Time frame: perioperatively/periprocedurally
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2036, 120 months later.
Of 45 observational studies under Leiomyoma, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 99. This study's planned 120 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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