A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: total hysterectomy, subtotal hysterectomy.
- Who it may be relevant to
- Registry conditions: Fibroid Uterus, Metrorrhagia, Adenomyosis, Benign Gynecologic Neoplasm. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Long-Term Outcomes Following Laparoscopic Total Vs Supracervical Hysterectomy, a Randomized Clinical Trial
Overview
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.
Interventions
- Procedure total hysterectomy
Total hysterectomy (TH) involves the complete removal of the uterus including the cervix - Procedure subtotal hysterectomy
subtotal hysterectomy (STH) preserves the cervix while removing the upper part of the uterus
Primary outcome measures
- Quality of life and patient's impression of improvement at 36 months after surgery [Time frame: 5 years]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica — Rome
Identifiers
NCT: NCT06802198 · 6429