Trial Outcomes & Findings for Trendelenburg's Slide Prevention Study (NCT NCT01068821)
NCT ID: NCT01068821
Last Updated: 2012-05-15
Results Overview
Patients undergoing gynecologic surgery require steep (30 to 45 degree) Trendelenberg's position to allow adequate exposure of the pelvis. This position leads to a small amount of movement toward the head of the bed. The table was marked at the point of the anterior superior iliac spine (ASIS) and at the point where a vertical marker touching the acromioclavicular (AC) joint of the left shoulder drops to the table. At the end of the surgery, when the operating table is leveled, the final positions of ASIS and AC will be measured. Measurements were made in centimeters to the tenth position.
COMPLETED
NA
60 participants
About 150 minutes after start of surgery
2012-05-15
Participant Flow
Patients with planned laparoscopic or robotic procedures were offered participation in the preoperative holding area. Recruitment started 3/1/2010 and ended 5/10/2010.
Patients were enrolled if they acknowledged their desire to participate. Patients were excluded if they were brought to the operating room before being approached for participation or if they indicated they did not wish to participate. The materials being compared are already both commonly used for gynecologic surgery.
Participant milestones
| Measure |
Egg Crate Foam Mattress
Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
|
Gel Pad
Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trendelenburg's Slide Prevention Study
Baseline characteristics by cohort
| Measure |
Egg Crate Foam Mattress
n=31 Participants
Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
|
Gel Pad
n=29 Participants
Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age Continuous
|
55.5 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: About 150 minutes after start of surgeryPopulation: Study size calculation was performed for 80% power, and p=0.05
Patients undergoing gynecologic surgery require steep (30 to 45 degree) Trendelenberg's position to allow adequate exposure of the pelvis. This position leads to a small amount of movement toward the head of the bed. The table was marked at the point of the anterior superior iliac spine (ASIS) and at the point where a vertical marker touching the acromioclavicular (AC) joint of the left shoulder drops to the table. At the end of the surgery, when the operating table is leveled, the final positions of ASIS and AC will be measured. Measurements were made in centimeters to the tenth position.
Outcome measures
| Measure |
Egg Crate Foam Mattress
n=30 Participants
Patient positioned on egg crate foam mattress during surgery
|
Gel Pad
n=29 Participants
Patient positioned on gel pad during surgery
|
|---|---|---|
|
Amount of Patient Movement on the Operating Room Table
|
3.2 centimeters
Standard Deviation 1.9
|
4.5 centimeters
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: postoperative day 1 and postoperative week 3-8Population: Participants were analyzed per protocol if they returned for postoperative followup (59 of 60 were analyzed)
The neurologic deficit was assessed as follows: Patients' postoperative care was unchanged from routine for this study. Any postoperative complaints regarding limb pain or weakness or numbness were recorded and assessed with neurologic exam to determine sensation or motor components. Absence of resolution was documented.
Outcome measures
| Measure |
Egg Crate Foam Mattress
n=30 Participants
Patient positioned on egg crate foam mattress during surgery
|
Gel Pad
n=29 Participants
Patient positioned on gel pad during surgery
|
|---|---|---|
|
Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery
|
0 participants
0
|
3 participants
0.19
|
Adverse Events
Egg Crate Foam Mattress
Gel Pad
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place