Clinical trial · Interventional
A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes
Comparison of Long-Term Outcomes Following Laparoscopic Total Vs Supracervical Hysterectomy, a Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abnormal Uterine Bleeding | — | UNRESOLVED | — |
| Adenomyosis | — | UNRESOLVED | — |
| Benign Gynecologic Neoplasm | Benign Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Endometriosis | — | UNRESOLVED | — |
| Fibroid Uterus | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Metrorrhagia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| subtotal hysterectomy | Procedure | — | UNRESOLVED |
| total hysterectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- patients undergoing total hysterectomy
- description
- Total hysterectomy involves the complete removal of the uterus including the cervix
- interventionNames
- Procedure: total hysterectomy
- type
- EXPERIMENTAL
- label
- patients undergoing subtotal hysterectomy
- description
- Subtotal hysterectomy involves the removal of the upper part of the uterus preserving the cervix
- interventionNames
- Procedure: subtotal hysterectomy
Primary outcomes (1)
- measure
- Quality of life and patient's impression of improvement at 36 months after surgery
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available