Clinical trial · Observational
4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial
NCT04637022CI-TRIAL-00049629unknownClinicalTrials.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)
This prospective randomized trial aims to assess if the operative time of vaginal cuff suture performed by trainees could be reduced using 3D laparoscopy instead of 4K 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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- 3D laparoscopy arm
- description
- Patients submitted to vaginal cuff closure after total laparoscopic hysterectomy using a 3D laparoscopic camera
- label
- 4k laparoscopy arm
- description
- Patients submitted to vaginal cuff closure after total laparoscopic hysterectomy using a 4k laparoscopic camera
Primary outcomes (1)
- measure
- operative time
- timeFrame
- intra-operative
- description
- To compare the time taken to close the vaginal cuff, which was defined as time, starting from the initial grasp of the suture to cutting the suture, with 3D Laparoscopy vs 4K laparoscopy
Secondary outcomes (1)
- measure
- Intra-operative complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Patients suffering from benign gynecological pathology (uterine fibromatosis, abnormal blood loss, complex hyperplasia with atypia, uterine prolapse) with indication for total uterine hysterectomy and consequently need for laparoscopic suture of the vaginal cuff * American Society of Anesthesiologists (ASA) class \< 3 * Patient's informed consent Exclusion Criteria: * Suspected neoplastic pathology * Patients not eligible for surgery * Actual pregnancies or pelvic inflammatory disease
References
Publications (0)
Data not yet available
No reference posted for this study.