A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes

Condition(s) studied

Investigational drug(s) / intervention(s)

total hysterectomy: Total hysterectomy (TH) involves the complete removal of the uterus including the cervix

subtotal hysterectomy: subtotal hysterectomy (STH) preserves the cervix while removing the upper part of the uterus

Study 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.

Eligibility

Primary outcome measure(s)

• Quality of life and patient's impression of improvement at 36 months after surgery — 5 years
  To assess the impact of surgery on patients' quality of life measured by the Physical Functioning items of SF36 questionnaire, at 36 months after surgery

Trial sites (1)

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