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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
500
Total hysterectomy (TH) involves the complete removal of the uterus including the cervix
subtotal hysterectomy (STH) preserves the cervix while removing the upper part of the uterus
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica
Rome, Lazio, Italy
Quality of life and patient's impression of improvement at 36 months after surgery
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
Time frame: 5 years
Postoperative pain
Post-operative pain will be evaluated using the visual analog scale (VAS) score, every 6 hours from the end of surgery, up to 48 hours.
Time frame: 5 years
Intra-operative data
To compare of operative time, estimated blood loss, associated procedures, and need for conversion to other techniques.
Time frame: 5 years
intraoperative complications
To evaluate the occurrence of intraoperative complications according to the modified Satava classification system. Grade 1 complications include incidents without consequences for the patient; grade 2 complications, which are treated intraoperatively with endoscopic surgery (grade 2a) or required endoscopic re-treatment (grade 2b); and grade 3 complications include incidents requiring open or laparoscopic surgery.
Time frame: 5 years
short and long-term postoperative complications
To evaluate the occurrence of postoperative complications according to the Clavien-Dindo classification and to evaluate the occurrence of long-term complications, including vaginal cuff dehiscence, up to 36 months post-operatively
Time frame: 5 years
Urinary, bowel and pelvic floor symptoms
To evaluate the impact of surgery on other urinary and bowel symptoms, with particular attention to 'de novo' symptoms, and long-term occurrence of pelvic organ prolapse or pelvic floor dysfunction.
Time frame: 5 years
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