Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 12, 2010
April 16, 2012
March 2010
August 2011   (final data collection date for primary outcome measure)
Amount of Patient Movement on the Operating Room Table [ Time Frame: About 150 minutes after start of surgery ] [ Designated as safety issue: No ]
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.
Amount of patient movement on the operating room table (cm) [ Time Frame: at the end of Trendelenburg's position ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01068821 on ClinicalTrials.gov Archive Site
Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery [ Time Frame: postoperative day 1 and postoperative week 3-8 ] [ Designated as safety issue: Yes ]
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.
neurologic deficit in extremities after surgery [ Time Frame: postop day 1 and postop week 3-8 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Trendelenburg's Slide Prevention Study
Randomized Controlled Trial Comparing Commonly Used Techniques to Prevent Slippage During Steep Trendelenburg's Position

The purpose of this study is to compare two cushioning materials (a gel mattress and an egg-crate foam mattress) placed beneath patients undergoing gynecologic surgery to prevent patients from sliding toward the head of the bed during head-down positioning.

Our hypothesis is that the two materials will be equally good at preventing slide on the table and that slide will be less than 5 cm (<2 inches) on average.

Patient undergoing laparoscopic gynecologic surgery are often placed in steep (30 to 45 degrees) Trendelenburg's (head lower than feet) position. This helps the bowels to move towards the patient's head, making surgery in the pelvis safer. During surgery, if patients slide a great deal toward the head of the bed, nerve injury and hernia risk may be increased. Several techniques are in use to prevent patients from sliding on the bed during surgery, and of these, increasing the friction between a patient's skin and the bed surface appears to be the safest technique. Two materials are in use to increase this friction: a gel pad or an egg-crate foam mattress upon which the patient lies with bare skin. This study is comparing these two materials to see which material is associated with the LEAST amount of patient slide. Our hypothesis is that the two materials will be equally good at preventing slide on the table and that slide will be less than 5 cm (<2 inches) on average.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Misadventure During Surgical Operation
  • Postoperative Complications
  • Other: Gel pad
    A gel pad (mattress) (approximately 3cm thick) is placed under the patient on top of the usual operating room mattress, directly in contact with patient's skin from buttocks to shoulders with the patient in dorsal lithotomy position under general anesthesia. Time in Trendelenburg's position and time operating are both recorded. The position of two bony landmarks (left anterior superior iliac spine and left acromioclavicular joint) are marked before Trendelenburg's position (30 to 45 degrees below horizontal) and immediately after returning the patient to horizontal position.
    Other Names:
    • Gel Pad:
    • Allen Medical
  • Other: Egg crate foam mattress
    An egg-crate foam mattress (approximately 5cm thick) is placed under the patient on top of the usual operating room mattress, directly in contact with patient's skin from buttocks to shoulders with the patient in dorsal lithotomy position under general anesthesia. Time in Trendelenburg's position and time operating are both recorded. The position of two bony landmarks (left anterior superior iliac spine and left acromioclavicular joint) are marked before Trendelenburg's position (30 to 45 degrees below horizontal) and immediately after returning the patient to horizontal position.
    Other Names:
    • Pink Foam:
    • Kendall Company, Ref# 31163457
  • Active Comparator: 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).
    Intervention: Other: Egg crate foam mattress
  • Active Comparator: Gel pad
    Patients will be placed on gel pad 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).
    Intervention: Other: Gel pad
Klauschie J, Wechter ME, Jacob K, Zanagnolo V, Montero R, Magrina J, Kho R. Use of anti-skid material and patient-positioning to prevent patient shifting during robotic-assisted gynecologic procedures. J Minim Invasive Gynecol. 2010 Jul-Aug;17(4):504-7. doi: 10.1016/j.jmig.2010.03.013. Epub 2010 May 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women undergoing gynecologic laparoscopic or robotic-assisted laparoscopic surgery
  • Trendelenburg's position is planned
  • General anesthesia is planned

Exclusion Criteria:

  • Patients with intolerance of Trendelenburg's position
  • Patients whose surgery are converted to laparotomy
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01068821
09-000685-01
No
Mary Ellen Wechter, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Mary E Wechter, MD, MPH Mayo Clinic, Baptist Medical Center
Mayo Clinic
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP