NCT06802198Not yet recruiting
A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes
Comparison of Long-Term Outcomes Following Laparoscopic Total Vs Supracervical Hysterectomy, a Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 27 Jan 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Endometriosis
- NCT number
- NCT06802198
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 1 Oct 2025 to the primary completion date, 1 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Uterine or adnexal pathology suspect for malignancy
Age
- Age \> 80 years
Other
- Abnormal or unknown PAP test
- Pregnant patients
- Desire for further pregnancies
- Contraindications to general anaesthesia or to the Trendelenburg position
- Refusal to sign informed consent
Who the study is looking for
- Age\>18 years
- Signed informed consent
Age in the registry: 18 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.