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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients undergoing total hysterectomy | Active Comparator | Total hysterectomy involves the complete removal of the uterus including the cervix |
|
| patients undergoing subtotal hysterectomy | Experimental | Subtotal hysterectomy involves the removal of the upper part of the uterus preserving the cervix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total hysterectomy | Procedure | Total hysterectomy (TH) involves the complete removal of the uterus including the cervix |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Intra-operative data | To compare of operative time, estimated blood loss, associated procedures, and need for conversion to other techniques. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Panico, MD | Contact | +390630153567 | giovanni.panico@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Giovanni Panico, MD | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica | Rome | Lazio | 00168 | Italy |
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| subtotal hysterectomy | Procedure | subtotal hysterectomy (STH) preserves the cervix while removing the upper part of the uterus |
|
| 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. | 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 | 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. | 5 years |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D008796 | Metrorrhagia |
| D062788 | Adenomyosis |
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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