A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jan 27, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to compare two types of surgical procedures for women with certain benign (non-cancerous) conditions affecting the uterus, such as fibroids and abnormal bleeding. The study will look at the long-term effects of total laparoscopic hysterectomy (removing the entire uterus) versus subtotal laparoscopic hysterectomy (removing only part of the uterus) along with a small incision for extracting the uterus. Researchers aim to see how these surgeries impact patients' quality of life three years after the operation, as well as their experiences regarding pain, recovery time, and any complications.

To be eligible for this trial, participants should be women over 18 years old who can provide informed consent. However, some women may not qualify, including those with suspected cancers or certain medical conditions, those who are pregnant, or those who wish to have more children in the future. Participants will fill out questionnaires before and after the surgery, which will help assess their health and satisfaction with the surgery. This trial is not yet recruiting, so there’s still time to learn more before deciding to participate.

Gender

FEMALE

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