A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this 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.

Eligibility criteria

Qualifiers

Age>18 years

Signed informed consent

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • total hysterectomy
  • subtotal hysterectomy

Treatment groups

500 Participants
are divided into 2 treatment groups