Trendelenburg's Slide Prevention Study (SPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mary Ellen Wechter, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01068821
First received: February 12, 2010
Last updated: April 16, 2012
Last verified: April 2012
Results First Received: August 15, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Misadventure During Surgical Operation
Postoperative Complications
Interventions: Other: Gel pad
Other: Egg crate foam mattress

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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).

Participant Flow:   Overall Study
    Egg Crate Foam Mattress     Gel Pad  
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).
Total Total of all reporting groups

Baseline Measures
    Egg Crate Foam Mattress     Gel Pad     Total  
Number of Participants  
[units: participants]
  31     29     60  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     23     22     45  
>=65 years     8     7     15  
Age  
[units: years]
Mean ± Standard Deviation
  55.5  ± 11.8     53.6  ± 12.7     54.6  ± 12.2  
Gender  
[units: participants]
     
Female     31     29     60  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     31     29     60  



  Outcome Measures
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1.  Primary:   Amount of Patient Movement on the Operating Room Table   [ Time Frame: About 150 minutes after start of surgery ]

2.  Secondary:   Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery   [ Time Frame: postoperative day 1 and postoperative week 3-8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: wechter.mary@mayo.edu


Publications:

Responsible Party: Mary Ellen Wechter, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01068821     History of Changes
Other Study ID Numbers: 09-000685-01
Study First Received: February 12, 2010
Results First Received: August 15, 2011
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board