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Which hysterectomy is better? new trial aims to find out

NCT ID NCT06802198

Symptom relief Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares total laparoscopic hysterectomy (removing the whole uterus including the cervix) with subtotal laparoscopic hysterectomy (keeping the cervix) in 500 women with benign conditions like fibroids or endometriosis. The main goal is to see which surgery leads to better quality of life and patient satisfaction three years later. Researchers will also track pain, recovery, and complications to guide future surgical choices.

What this could mean

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

Active substance
laparoscopic hysterectomy (total or subtotal)
What this could lead to
If successful, this could help doctors choose the best hysterectomy type for each patient, improving long-term quality of life and reducing complications.
What could go wrong
This is a surgical comparison study, not a new treatment. Results may not apply to all patients, and individual outcomes can vary based on surgeon skill and patient health.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Feb 2030

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.

Ages

18 to 80 years

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: * Age\>18 years * Signed informed consent Exclusion Criteria: * Uterine or adnexal pathology suspect for malignancy * Abnormal or unknown PAP test * Patients with invasive neoplasia in the previous 5 years (excluding non-melanoma skin tumors, breast cancer T1 N0 M0 Grade 1 or 2 without signs of recurrence or activity). * Previous radical pelvic surgery or radiotherapy; * Age \> 80 years * Pregnant patients * Desire for further pregnancies * Contraindications to general anaesthesia or to the Trendelenburg position * Refusal to sign informed consent

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Conditions

The condition(s) this trial relates to.

adenomyosis benign female reproductive system neoplasm endometriosis leiomyoma Metrorrhagia uterine corpus leiomyoma

As listed by the trial registrant

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

Abnormal uterine bleeding Adenomyosis Benign gynecologic neoplasm Endometriosis Fibroid uterus Metrorrhagia

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

  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica

    Rome, Lazio, 00168, Italy

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