N/A
Completed N=80
3D Versus 2D Laparoscopic Ovarian Cystectomy
Surgical Procedure, Unspecified
Source: ClinicalTrials.gov NCT02775344 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: The Duration of Laparoscopic Ovarian Cystectomy — 51.6; 47.6 minutes — p=0.198
Summary
This is a prospective randomized study involving 80 patients. All participates will be given written information on 3D laparoscopy. They will be randomized according to computer-generated random sequence into two groups, 2D and 3D group. The operation will then be performed either using 2D or 3D laparoscopy. Surgeons are allowed to change to the other type of laparoscopy if difficulty encountered. After the operation, the surgeons will be required to fill in a questionnaire self-evaluating the performance using Global rating scale component of the intraoperative assessment tool (GOALS), any discomfort encountered, any need for change of laparoscopy and their preference on the type of laparoscopy.
The level of complexity of the operation, duration of operation, blood loss and complications will be recorded.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Duration of Laparoscopic Ovarian Cystectomy |
51.6; 47.6 | 0.198 |
| PRIMARY Global Rating Scale Component of the Intraoperative Assessment Tool (GOALS) Score |
20.1; 20.8 | 0.393 |
| SECONDARY Number of Surgeons Encountered Side Effects |
17; 2 | — |
| SECONDARY Preference of Surgeons |
7; 0; 16; 9; 14; 29 | — |
| SECONDARY Need for Change of Instrument |
0; 0 | — |
| SECONDARY Total Blood Loss During Operation |
58.2; 55.1 | — |
| SECONDARY Duration of Hospital Stay |
2.4; 2.6 | — |
Eligibility Criteria
Inclusion Criteria
- Planned for laparoscopic ovarian cystectomy
- Willing and able to participate after the study has been explained
- Those understand either Cantonese, Putonghua or English
Exclusion Criteria
- essential data are missing from the participants records making it impossible to judge treatment outcome.
Data sourced from ClinicalTrials.gov (NCT02775344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.