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.
Age>18 years
Signed informed consent
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;
Parallel
total hysterectomy
Procedure/SurgeryTotal hysterectomy (TH) involves the complete removal of the uterus including the cervix
subtotal hysterectomy
Procedure/Surgerysubtotal hysterectomy (STH) preserves the cervix while removing the upper part of the uterus
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
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.
Intra-operative data
To compare of operative time, estimated blood loss, associated procedures, and need for conversion to other techniques.
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.
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
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
