Benign Gynecological DiseaseOPGYNBENNCT07772076
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
An observational study of Benign Gynecological Disease and Uterine Fibroids, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This prospective observational registry aims to systematically collect preoperative, intraoperative, and postoperative clinical data from patients undergoing surgery for benign gynecological conditions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Benign Gynecological Disease, Uterine Fibroids, Endometriosis
- What is being tested?
- Standard Surgical Procedures for Benign Gynecological Conditions
- Type of treatment
- Surgery or procedure
- How many people
- 6,000 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2026to Sep 2039
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age >= 18 years
- 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)
- Indication for elective benign gynecological surgery
- Signed written informed consent for data collection
Who cannot join
- Age < 18 years
- Suspected or confirmed malignant gynecological disease
- Current pregnancy
- Emergency / unscheduled surgical procedure
- No indication for surgery
- Refusal or inability to provide signed 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.
Giorgio Candotti, MD contact
Italy1 site
IRCCS Ospedale San Raffaele - U.O. Ginecologia e Ostetricia
Milan, Milano
Massimo Candiani, MD, Professor, +39 02-26432653, candiani.massimo@hsr.it
Massimo Candiani, MD, Professor
About this study
Official title: Prospective Observational Registry on the Collection of Perioperative Clinical Data in Gynecology
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.
Read the 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.
- Conditions
- Benign Gynecological Disease, Uterine Fibroids, Endometriosis, Adenomyosis, Pelvic Adhesions, Ovarian Cyst Benign
- Being tested
- Standard Surgical Procedures for Benign Gynecological 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
- Medical subject headings
- Leiomyoma, Endometriosis, Adenomyosis, Salpingitis, Pregnancy, Ectopic, Myofibroma, Pelvic Pain, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Surgical Procedures for Benign Gynecological ConditionsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Gynecological Surgery Cohort | Women with indication for elective benign gynecological surgery undergoing standard clinical surgical procedures (laparoscopy, laparotomy, vaginal, robotic, hysteroscopy, vNOTES). Receives: Procedure: Standard Surgical Procedures for Benign Gynecological Conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative and Postoperative Complications
Incidence and severity of intraoperative and postoperative complications categorized according to the Clavien-Dindo classification
Measured: perioperatively/periprocedurally
Secondary outcomes (4)
Operative Time
Total duration of the surgical procedure measured from skin incision to skin closure, reported in minutes
Measured: perioperatively/periprocedurally
Surgical Blood Loss
Estimated total intraoperative blood loss measured in milliliters (mL)
Measured: perioperatively/periprocedurally
Length of Hospital Stay
Total duration of hospitalization from admission for surgery to hospital discharge, reported in days
Measured: 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
Measured: perioperatively/periprocedurally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2036 (estimated)
- Study completionSep 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Gynecological DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Candiani, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772076
- Sponsor's protocol ID
- CET 111-2026
- Acronym
- OPGYNBEN
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Registry on the Collection of Perioperative Clinical Data in Gynecology
- ClinicalTrials.gov ID
- NCT07772076
- Acronym / sponsor ID
- OPGYNBEN / CET 111-2026
- Conditions
- Benign Gynecological Disease, Uterine Fibroids, Endometriosis, Adenomyosis, Pelvic Adhesions, Ovarian Cyst Benign
- Keywords
- Gynecological Surgery, Perioperative Data, Laparoscopy, uterine fibroids, endometriosis, Registry, Uterine Myoma, Pelvic Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2036 (estimated)
- Study completion
- Sep 2039 (estimated)
- First posted
- 19 Aug 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynecological Surgery Cohort | – | Procedure: Standard Surgical Procedures for Benign Gynecological ConditionsWomen with indication for elective benign gynecological surgery undergoing standard clinical surgical procedures (laparoscopy, laparotomy, vaginal, robotic, hysteroscopy, vNOTES). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Age >= 18 years
- 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)
- Indication for elective benign gynecological surgery
- Signed written informed consent for data collection
Key exclusion criteria (6 listed)
- Age < 18 years
- Suspected or confirmed malignant gynecological disease
- Current pregnancy
- Emergency / unscheduled surgical procedure
- No indication for surgery
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 |
|---|---|---|
| Standard Surgical Procedures for Benign Gynecological ConditionsPatients 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. | Procedure or surgery | Gynecological Surgery Cohort |
Primary outcome
Intraoperative and Postoperative Complications
Time frame: perioperatively/periprocedurally
Incidence and severity of intraoperative and postoperative complications categorized according to the Clavien-Dindo classification
4 secondary outcomes
Operative Time
Time frame: perioperatively/periprocedurally
Surgical Blood Loss
Time frame: perioperatively/periprocedurally
Length of Hospital Stay
Time frame: up to 30 days
Post-operative Pain Score
Time frame: perioperatively/periprocedurally
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 19 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Benign Gynecological Disease
Recruiting
vNOTES Versus Vaginal Hysterectomy for Benign Gynecologic Indications
Hysterectomy, Benign Uterine Diseases
Recruiting
Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES Hysterectomy
Leiomyoma, Uterine, Benign Gynecological Disease
Recruiting
Impact of Time on Sexual Function (FSFI® Score) After Hysterectomy
Time Between Hysterectomy and Resumption of Sexual Relations, Sexual Function
Active, not recruitingObservational study
The Learning Curve of a Gynecology and Obstetrics Resident Performing Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) Hysterectomy in a University Hospital
Abnormal Uterine Bleeding, Unspecified, Benign Gynecological Disease
Recruiting
Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach
Gynecologic Disease, Adnexal Mass
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.
Giorgio Candotti, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Gynecological Disease and Uterine Fibroids, run by IRCCS San Raffaele 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 4 inclusion and 6 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 19 Aug 2026. 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 Massimo Candiani, MD, Prof (+39 02-26432653, candiani.massimo@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative and Postoperative Complications (time frame: perioperatively/periprocedurally). 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 19 Aug 2026.