Clinical trial · Observational
Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?
2D Versus 3D Total Laparoscopic Hysterectomy by Surgeons in Training: a Prospective Randomized Trial
NCT04209036CI-TRIAL-00042454unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
Due to the inconclusive results on the benefits of 3D laparoscopic system present in literature, this prospective randomised pilot study aims to assess if the operative time of total laparoscopic hysterectomy (TLH) for benign indication performed by trainees could be reduced using 3D laparoscopy instead of standard laparoscopy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Bleeding | — | UNRESOLVED | — |
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Uterine Prolapse | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 3D laparoscopy arm
- description
- patients submitted to total hysterectomy using a 3D laparoscopic camera
- interventionNames
- Other: 0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)
- label
- 2D laparoscopy arm
- description
- patients submitted to total hysterectomy using a 2D laparoscopic camera (standard laparoscopic camera)
Primary outcomes (1)
- measure
- Operative time
- timeFrame
- intra-operative
- description
- To compare operative time for Total Laparoscopic Hysterectomy with 3D laparoscopy vs. conventional laparoscopy
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Patients suffering from benign uterine pathology (uterine fibromatosis, abnormal blood loss, complex hyperplasia with atypia, uterine prolapse) with indication for total uterine hysterectomy * Uterine size \</= than 15 cm * American Society of Anesthesiologists (ASA) class \< 3 * Patient's informed consent * No actual pregnancies or pelvic inflammatory disease * No previous major abdominal surgical procedures Exclusion Criteria: * Suspected neoplastic pathology * Patients not eligible for surgery
References
Publications (1)
- DERIVEDRestaino S, Vargiu V, Rosati A, Bruno M, Dinoi G, Cola E, Moroni R, Scambia G, Fanfani F. 4K versus 3D total laparoscopic hysterectomy by resident in training: a prospective randomised trial. Facts Views Vis Obgyn. 2021 Sep;13(3):221-229. doi: 10.52054/FVVO.13.3.027. PMID 34555876