N/A N=80 Randomized Treatment

3D Versus 2D Laparoscopic Ovarian Cystectomy

Surgical Procedure, Unspecified

Bottom Line

View on ClinicalTrials.gov: NCT02775344 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: The Duration of Laparoscopic Ovarian Cystectomy — 51.6; 47.6 minutes — p=0.198

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Three dimension laparoscopy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Queen Mary Hospital, Hong Kong
Primary completion: May 2016

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.