Clinical Research Directory

A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Summary

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.

Official title: Comparison of Long-Term Outcomes Following Laparoscopic Total Vs Supracervical Hysterectomy, a Randomized Clinical Trial

Key Details

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Interventions

Locations (1)