Abnormal Uterine Bleeding, Adenomyosis, Benign Gynecologic Neoplasm, Endometriosis, Fibroid Uterus, Metrorrhagia
Conditions
Brief 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.
Interventions
PROCEDUREtotal hysterectomy
Total hysterectomy (TH) involves the complete removal of the uterus including the cervix
PROCEDUREsubtotal hysterectomy
subtotal hysterectomy (STH) preserves the cervix while removing the upper part of the uterus
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age\>18 years * Signed informed consent
Exclusion criteria
* 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; * Age \> 80 years * Pregnant patients * Desire for further pregnancies * Contraindications to general anaesthesia or to the Trendelenburg position * Refusal to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 5 years | 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 | 5 years | To compare of operative time, estimated blood loss, associated procedures, and need for conversion to other techniques. |
| intraoperative complications | 5 years | 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 | 5 years | 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 |
| Urinary, bowel and pelvic floor symptoms | 5 years | 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. |
Countries
Italy
Contacts
Primary ContactGiovanni Panico, MD
Outcome results
None listed