Compares two keyhole womb removal surgeries for benign uterine conditions
Compares full and partial laparoscopic hysterectomy in women with fibroids or heavy bleeding.
Plain-language title generated from the registry record
Registry title: A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes
Key facts
- Where
- Rome, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06802198, who can take part
Where in Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia OncologicaRome, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT06802198
- Record updated
- 5 September 2025
- Original description
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).Read full original descriptionShow less
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.
Inclusion: Age>18 years; Signed informed consent.
Exclusion: 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; Uterine or adnexal pathology suspect for malignancy; Age > 80 years; 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.