Clinical trial · Interventional
2-D and 3-D Laparoscopic Hysterectomy
3-dimensional Versus Conventional Laparoscopy in Patients Undergoing Total Hysterectomy for Benign Disease - A Randomised 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)
Background: No randomised trials have been conducted, and only a single retrospective study exists comparing 3D and 2D laparoscopic hysterectomy. In that study, operative time for hysterectomy was significantly lower for 3D compared to 2D conventional laparoscopy. Complication rates were similar for the two groups. Thus, although one out of nine women is hysterectomized and although laparoscopy is one of the recommended routes of surgery, evidence whether to choose 2D laparoscopy, 3D laparoscopy is sparse. Objective: To compare pain and recurrence to usual activity level. Secondary to compare complications during the operation, postoperative complications, time to return to work, length of hospital stay and operative time. Design: Investigator-initiated, blinded, randomised controlled trial. Intervention description: Operative procedures follow the same principles and the same standard whether the surgeon's vision is 2D or 3D. Trial size Roskilde/Herlev Hospital, Denmark: 200 patients in each arm of the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroma, Bleeding | Fibroma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2-D laparoscopy | Device | — | UNRESOLVED |
| 3-D laparoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 2-Dimensional laparoscopic hysterectomy
- description
- traditional 2-D laparoscopy
- interventionNames
- Device: 2-D laparoscopy
- type
- EXPERIMENTAL
- label
- 3-Dimensional laparoscopic hysterectomy
- description
- experimental 3-D laparoscopy
- interventionNames
- Device: 3-D laparoscopy
Primary outcomes (2)
- measure
- Score on SF 36 psychical health survey 6 weeks after surgery
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients referred for laparoscopic hysterectomy with or without bilateral salpingectomy or bilateral salpingooophorectomy for benign indications. Exclusion Criteria: * Women not suitable for laparoscopic hysterectomy including: * Ultrasound appraisal of uterus weight \> 1000 gram * Need for prolapse surgery and therefore indication for vaginal hysterectomy. * Inability to give informed consent
References
Publications (1)
- DERIVEDHoffmann E, Bennich G, Larsen CR, Lindschou J, Jakobsen JC, Lassen PD. 3-dimensional versus conventional laparoscopy for benign hysterectomy: protocol for a randomized clinical trial. BMC Womens Health. 2017 Sep 7;17(1):76. doi: 10.1186/s12905-017-0434-7. PMID 28882141