Trial Outcomes & Findings for Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? (NCT NCT02192606)
NCT ID: NCT02192606
Last Updated: 2018-01-24
Results Overview
The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
Start of vaginal cuff closure to end of vaginal cuff closure
Results posted on
2018-01-24
Participant Flow
Participant milestones
| Measure |
2D Laparoscopy
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
|
3D Laparoscopy
The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
27
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
2D Laparoscopy
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
|
3D Laparoscopy
The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
|
|---|---|---|
|
Overall Study
surgery type was changed
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
3D equipment rep unable to join
|
0
|
1
|
Baseline Characteristics
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?
Baseline characteristics by cohort
| Measure |
2D Laparoscopy
n=29 Participants
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
|
3D Laparoscopy
n=28 Participants
The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.5 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
42.7 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Start of vaginal cuff closure to end of vaginal cuff closureThe primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.
Outcome measures
| Measure |
2D Laparoscopy
n=29 Participants
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
|
3D Laparoscopy
n=28 Participants
The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
|
|---|---|---|
|
Vaginal Cuff Closure Times
|
10.17 minutes
Standard Deviation 5.98
|
12.54 minutes
Standard Deviation 6.99
|
SECONDARY outcome
Timeframe: Time of Procedure EndThe secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.
Outcome measures
| Measure |
2D Laparoscopy
n=29 Participants
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
|
3D Laparoscopy
n=28 Participants
The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
|
|---|---|---|
|
Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy
|
55.74 millileters
Standard Deviation 39.36
|
60.83 millileters
Standard Deviation 62.32
|
Adverse Events
2D Laparoscopy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
3D Laparoscopy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2D Laparoscopy
n=29 participants at risk
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
|
3D Laparoscopy
n=28 participants at risk
The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
ER visit
|
0.00%
0/29 • Adverse event data was collected from the day of surgery to 8 weeks following the operation.
|
3.6%
1/28 • Number of events 1 • Adverse event data was collected from the day of surgery to 8 weeks following the operation.
|
|
Surgical and medical procedures
Reoperation for vaginal cuff dehiscence
|
0.00%
0/29 • Adverse event data was collected from the day of surgery to 8 weeks following the operation.
|
3.6%
1/28 • Number of events 1 • Adverse event data was collected from the day of surgery to 8 weeks following the operation.
|
|
Skin and subcutaneous tissue disorders
Iritation around abdominal surgical incision site
|
0.00%
0/29 • Adverse event data was collected from the day of surgery to 8 weeks following the operation.
|
3.6%
1/28 • Number of events 1 • Adverse event data was collected from the day of surgery to 8 weeks following the operation.
|
|
Infections and infestations
Incision cellulitis
|
0.00%
0/29 • Adverse event data was collected from the day of surgery to 8 weeks following the operation.
|
3.6%
1/28 • Number of events 1 • Adverse event data was collected from the day of surgery to 8 weeks following the operation.
|
|
Infections and infestations
Yeast infection
|
3.4%
1/29 • Number of events 1 • Adverse event data was collected from the day of surgery to 8 weeks following the operation.
|
0.00%
0/28 • Adverse event data was collected from the day of surgery to 8 weeks following the operation.
|
|
Injury, poisoning and procedural complications
Intraoperative complication
|
3.4%
1/29 • Number of events 1 • Adverse event data was collected from the day of surgery to 8 weeks following the operation.
|
0.00%
0/28 • Adverse event data was collected from the day of surgery to 8 weeks following the operation.
|
|
General disorders
Urinary retention
|
3.4%
1/29 • Number of events 1 • Adverse event data was collected from the day of surgery to 8 weeks following the operation.
|
0.00%
0/28 • Adverse event data was collected from the day of surgery to 8 weeks following the operation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place