Clinical trial · Interventional
2D Versus 3D Radical Laparoscopic Hysterectomy for Cervical Cancer: a Prospective Randomized Trial
Prospective Randomized Trial on2D Versus 3D Laparoscopic Radical Hysterectomy With Pelvic Lymphadenectomy for the Treatment of Early Stage Cervical Cancer (FIGO Stages IA2-IB1-IIA<2cm) and Advanced Stage Cervical Cancer (FIGO Stages IB2-IIA>2 Cm-IIB) Submitted to NACT With Complete Clinical Response.
- 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 aim of this prospective randomized pilot study is to verify if the operative time of a Radical abdominal hysterectomy (LRH) with pelvic lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA\<2cm) and for advanced stage cervical cancer (FIGO stages IB2-IIA\>2cm-IIB) submitted to neoadjuvant chemotherapy (NACT) with complete clinical response could be further reduced using 3D Laparoscopy (Olympus Medical Systems Corp) versus standard laparoscopy
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laparoscopic Surgical Procedures | — | UNRESOLVED | — |
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D Laparoscopy | Procedure | — | UNRESOLVED |
| Standard Laparoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 3D Laparoscopy
- description
- Laparoscopic radical hysterectomy with pelvic lymphadenectomy are performed with 3D Laparoscopic technology. A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition 3D telescope. Two additional 5 mm ports are placed under direct visualization. One more 5- mm trocar is inserted in the right mid abdomen at the level of the umbilicus. The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system.
- interventionNames
- Procedure: 3D Laparoscopy
- type
- ACTIVE_COMPARATOR
- label
- Standard Laparoscopy
- description
- Laparoscopic radical hysterectomy with pelvic lymphadenectomy are performed with standard laparoscopy technology. A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition telescope. Two additional 5 mm ports are placed under direct visualization. One more 5 mm trocar is inserted in the right mid abdomen at the level of the umbilicus. The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 75 Years
Show eligibility criteria text
* Age ≤ 75 years * Patient's informed consent * American Society of Anesthesiologists: \< class III or IV * No actual pregnancies or P.I.D. * No previous major abdominal surgical procedures * Early stage cervical cancer (FIGO stages IA2-IB1-IIA\<2cm) and advanced stage cervical cancer (FIGO stages IB2-IIA\>2cm-IIB) submitted to NACT with complete clinical response * No previous radiotherapy on the pelvic field * No uterine size larger than conform 10 weeks gestation
References
Publications (0)
Data not yet available