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Can big data improve safety in gynecologic surgery?

NCT ID NCT07772076

Knowledge-focused Sponsor: IRCCS San Raffaele Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study is a large registry that will collect detailed information from thousands of women undergoing surgery for non-cancerous gynecologic conditions like fibroids, endometriosis, and ovarian cysts. The goal is to track surgical techniques, complications, and recovery in real-world practice. By analyzing this data, researchers hope to identify factors that lead to better outcomes and fewer complications, ultimately improving care for future patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Standard surgical procedures for benign gynecological conditions
What this could lead to
If successful, this registry could identify best practices and risk factors, leading to improved surgical outcomes and fewer complications for women undergoing gynecologic surgery.
What could go wrong
As an observational registry, it cannot prove cause and effect. Data quality depends on real-world reporting, and findings may not change practice without further studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 6,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2039

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

adenomyosis adhesions of uterus ectopic pregnancy endometrial polyp endometriosis leiomyoma myofibroma ovarian cyst Pelvic Pain Postoperative Complications salpingitis uterine corpus leiomyoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adenomyosis Benign gynecological disease Ectopic pregnancy Endometriosis Ovarian cyst benign Pelvic adhesions Polyp endometrium Salpingitis Uterine fibroids

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS Ospedale San Raffaele - U.O. Ginecologia e Ostetricia

    Milan, Milano, Italy

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