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Trendelenburg's Slide Prevention Study (SPS)

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ClinicalTrials.gov Identifier: NCT01068821
Recruitment Status : Completed
First Posted : February 15, 2010
Results First Posted : May 15, 2012
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):
Mary Ellen Wechter, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Misadventure During Surgical Operation
Postoperative Complications
Interventions Other: Gel pad
Other: Egg crate foam mattress
Enrollment 60
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Egg Crate Foam Mattress Gel Pad
Hide Arm/Group Description 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). 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).
Period Title: Overall Study
Started 31 29
Completed 30 [1] 29
Not Completed 1 0
[1]
1 patient had slide measured, but her patient ID not listed; couldn't do postoperative followup.
Arm/Group Title Egg Crate Foam Mattress Gel Pad Total
Hide Arm/Group Description 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). 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 of all reporting groups
Overall Number of Baseline Participants 31 29 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
  74.2%
22
  75.9%
45
  75.0%
>=65 years
8
  25.8%
7
  24.1%
15
  25.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 29 participants 60 participants
55.5  (11.8) 53.6  (12.7) 54.6  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
Female
31
 100.0%
29
 100.0%
60
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 29 participants 60 participants
31 29 60
1.Primary Outcome
Title Amount of Patient Movement on the Operating Room Table
Hide Description 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.
Time Frame About 150 minutes after start of surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study size calculation was performed for 80% power, and p=0.05
Arm/Group Title Egg Crate Foam Mattress Gel Pad
Hide Arm/Group Description:
Patient positioned on egg crate foam mattress during surgery
Patient positioned on gel pad during surgery
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: centimeters
3.2  (1.9) 4.5  (4.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Egg Crate Foam Mattress, Gel Pad
Comments Sample size calculations (yielding 25 patients per group): two-sided 5% significance level and a power of 80% for detection of a 2 cm (SD 2.5 cm) difference. Continuous variables analyzed by Student’s T-test and One way Analysis of Variance (ANOVA) with statistical significance: p value ≤ 0.05 or 95% Confidence Interval excluding one. Confirmation by Wilcoxon Rank-Sum/Mann-Whitney and Kruskal-Wallis tests. Categorical variables by Chi Square Test, confirmed by Fisher’s Exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery
Hide Description 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.
Time Frame postoperative day 1 and postoperative week 3-8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants were analyzed per protocol if they returned for postoperative followup (59 of 60 were analyzed)
Arm/Group Title Egg Crate Foam Mattress Gel Pad
Hide Arm/Group Description:
Patient positioned on egg crate foam mattress during surgery
Patient positioned on gel pad during surgery
Overall Number of Participants Analyzed 30 29
Measure Type: Number
Unit of Measure: participants
0 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Egg Crate Foam Mattress, Gel Pad
Comments Fischer's exact test, significance defined as p<0.05
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Participants were followed from randomization until final chart review at study end: Mean follow up surveillance of 344.9 days (SD 116.2)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Egg Crate Foam Mattress Gel Pad
Hide Arm/Group Description 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). 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).
All-Cause Mortality
Egg Crate Foam Mattress Gel Pad
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Egg Crate Foam Mattress Gel Pad
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Egg Crate Foam Mattress Gel Pad
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/29 (0.00%) 
Evaluation of postoperative outcomes was non-systematic using chart review for all participants except for one participant whose identity was not listed on data abstraction sheet.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Mary Ellen Wechter
Organization: Mayo Clinic, Florida
Phone: 904 412 7351
Responsible Party: Mary Ellen Wechter, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01068821     History of Changes
Other Study ID Numbers: 09-000685-01
First Submitted: February 12, 2010
First Posted: February 15, 2010
Results First Submitted: August 15, 2011
Results First Posted: May 15, 2012
Last Update Posted: May 15, 2012