Fibroid UterusSTORYNCT06802198
A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes
A study testing total hysterectomy and subtotal hysterectomy in people with Fibroid Uterus and Metrorrhagia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The goal of this randomized clinical trial is to assess the outcomes of total laparoscopic hysterectomy vs subtotal laparoscopic hysterectomy + mini-laparotomy for uterine extraction for benign gynecological conditions in terms of change in quality of life at 36 months after surgery and patient's impression of… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Fibroid Uterus, Metrorrhagia, Adenomyosis
- What is being tested?
- total hysterectomy and subtotal hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2025to 1 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years
- Signed informed consent
Who cannot join
- 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
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- Desire for further pregnancies
- Contraindications to general anaesthesia or to the Trendelenburg position
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica
Rome, Lazio, 00168
Giovanni Panico, MD, +390630153567, giovanni.panico@policlinicogemelli.it
Giovanni Panico, MD
About this study
Official title: Comparison of Long-Term Outcomes Following Laparoscopic Total Vs Supracervical Hysterectomy, a Randomized Clinical Trial
The goal of this randomized clinical trial is to assess the outcomes of total laparoscopic hysterectomy vs subtotal laparoscopic hysterectomy + mini-laparotomy for uterine extraction for benign gynecological conditions in terms of change in quality of life at 36 months after surgery and patient's impression of improvement. The secondary objectives of the study are to assess any differences in terms of peri and postoperative outcomes (postoperative pain, blood loss, hospital stay, intraoperative or short and long-term postoperative complications, long term urinary, bowel and pelvic floor symptoms, prevalence of vaginal cuff dehiscence).
Participants will fill the following questionnaires pre-operatively and at the follow up:
- Short Form 36 (SF36),
- Euro Quality of life 5D-3L (EQ 5D-3L)
- Female Sexual Function Index (FSFI)
- Patient Global Impression of Improvement (PGI-I) only during the follow-up period.
- Conditions
- Fibroid Uterus, Metrorrhagia, Adenomyosis, Benign Gynecologic Neoplasm, Endometriosis, Abnormal Uterine Bleeding
- Being tested
- total hysterectomy, subtotal hysterectomy
- Medical subject headings
- Leiomyoma, Metrorrhagia, Adenomyosis, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hysterectomyProcedure or surgery
Total hysterectomy (TH) involves the complete removal of the uterus including the cervix
subtotal hysterectomyProcedure or surgery
subtotal hysterectomy (STH) preserves the cervix while removing the upper part of the uterus
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing total hysterectomy | Active comparator | Total hysterectomy involves the complete removal of the uterus including the cervix Receives: Procedure: total hysterectomy |
| patients undergoing subtotal hysterectomy | Experimental | Subtotal hysterectomy involves the removal of the upper part of the uterus preserving the cervix Receives: Procedure: subtotal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life and patient's impression of improvement at 36 months after surgery
To assess the impact of surgery on patients' quality of life measured by the Physical Functioning items of SF36 questionnaire, at 36 months after surgery
Measured: 5 years
Secondary outcomes (5)
Postoperative pain
Post-operative pain will be evaluated using the visual analog scale (VAS) score, every 6 hours from the end of surgery, up to 48 hours.
Measured: 5 years
Intra-operative data
To compare of operative time, estimated blood loss, associated procedures, and need for conversion to other techniques.
Measured: 5 years
intraoperative complications
To evaluate the occurrence of intraoperative complications according to the modified Satava classification system. Grade 1 complications include incidents without consequences for the patient; grade 2 complications, which are treated intraoperatively with endoscopic surgery (grade 2a) or required endoscopic re-treatment (grade 2b); and grade 3 complications include incidents requiring open or laparoscopic surgery.
Measured: 5 years
short and long-term postoperative complications
To evaluate the occurrence of postoperative complications according to the Clavien-Dindo classification and to evaluate the occurrence of long-term complications, including vaginal cuff dehiscence, up to 36 months post-operatively
Measured: 5 years
Urinary, bowel and pelvic floor symptoms
To evaluate the impact of surgery on other urinary and bowel symptoms, with particular attention to 'de novo' symptoms, and long-term occurrence of pelvic organ prolapse or pelvic floor dysfunction.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroid UterusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Panico, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802198
- Sponsor's protocol ID
- 6429
- Acronym
- STORY
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Long-Term Outcomes Following Laparoscopic Total Vs Supracervical Hysterectomy, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06802198
- Acronym / sponsor ID
- STORY / 6429
- Conditions
- Fibroid Uterus, Metrorrhagia, Adenomyosis, Benign Gynecologic Neoplasm, Endometriosis, Abnormal Uterine Bleeding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized clinical trial is to assess the outcomes of total laparoscopic hysterectomy vs subtotal laparoscopic hysterectomy + mini-laparotomy for uterine extraction for benign gynecological conditions in terms of change in quality of life at 36 months after surgery and patient's impression of improvement. The secondary objectives of the study are to assess any differences in terms of peri and postoperative outcomes (postoperative pain, blood loss, hospital stay, intraoperative or short and long-term postoperative complications, long term urinary, bowel and pelvic floor symptoms, prevalence of vaginal cuff dehiscence).
Participants will fill the following questionnaires pre-operatively and at the follow up:
- Short Form 36 (SF36),
- Euro Quality of life 5D-3L (EQ 5D-3L)
- Female Sexual Function Index (FSFI)
- Patient Global Impression of Improvement (PGI-I) only during the follow-up period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients undergoing total hysterectomy | Active comparator | Procedure: total hysterectomyTotal hysterectomy involves the complete removal of the uterus including the cervix |
| patients undergoing subtotal hysterectomy | Experimental | Procedure: subtotal hysterectomySubtotal hysterectomy involves the removal of the upper part of the uterus preserving the cervix |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age>18 years
- Signed informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total hysterectomyTotal hysterectomy (TH) involves the complete removal of the uterus including the cervix | Procedure or surgery | patients undergoing total hysterectomy |
| subtotal hysterectomysubtotal hysterectomy (STH) preserves the cervix while removing the upper part of the uterus | Procedure or surgery | patients undergoing subtotal hysterectomy |
Primary outcome
Quality of life and patient's impression of improvement at 36 months after surgery
Time frame: 5 years
To assess the impact of surgery on patients' quality of life measured by the Physical Functioning items of SF36 questionnaire, at 36 months after surgery
5 secondary outcomes
Postoperative pain
Time frame: 5 years
Intra-operative data
Time frame: 5 years
intraoperative complications
Time frame: 5 years
short and long-term postoperative complications
Time frame: 5 years
Urinary, bowel and pelvic floor symptoms
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanni Panico, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total hysterectomy and subtotal hysterectomy in people with Fibroid Uterus and Metrorrhagia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Panico, MD (+390630153567, giovanni.panico@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life and patient's impression of improvement at 36 months after surgery (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.