Clinical trial · Interventional
Minimally Invasive Benign Hysterectomy
Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy
NCT01865929CI-TRIAL-00074649completedN/AClinicalTrials.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)
A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods; robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy; outcome and cost analyses.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Menorrhagia | — | UNRESOLVED | — |
| Metrorrhagia | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic hysterectomy | Device | — | UNRESOLVED |
| Vaginal or laparoscopic hysterectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Robotic hysterectomy
- description
- Minimally invasive hysterectomy by robotic surgery
- interventionNames
- Procedure: Vaginal or laparoscopic hysterectomy
- type
- ACTIVE_COMPARATOR
- label
- Vaginal or laparoscopic hysterectomy
- description
- Minimal invasive hysterectomy by vaginal or traditional laparoscopic surgery.
- interventionNames
- Device: Robotic hysterectomy
Primary outcomes (1)
- measure
- Cost of surgery
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer * size of uterus and vagina allows for retrieval by the vaginal route * maximum uterine size equivalent to 16 weeks of pregnancy * informed consent Exclusion Criteria: * malignant disease * known extensive intra-abdominal adhesions * anaesthesiological contraindications to laparoscopic surgery * women with pacemaker or other implants where electrosurgery is to be avoided * immunoincompetent women * simultaneous need for prolapse surgery * women with known defects of the hemostasis * allergies towards metronidazole and doxycycline * inability to understand patient information
References
Publications (0)
Data not yet available
No reference posted for this study.