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Trendelenburg's Slide Prevention Study (SPS)

Primary Purpose

Misadventure During Surgical Operation, Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gel pad
Egg crate foam mattress
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Misadventure During Surgical Operation focused on measuring Slide, Trendelenburg's position, Postoperative, neurologic complaints

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Egg crate foam mattress

Gel pad

Arm 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 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).

Outcomes

Primary Outcome Measures

Amount of Patient Movement on the Operating Room Table
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.

Secondary Outcome Measures

Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery
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.

Full Information

First Posted
February 12, 2010
Last Updated
April 16, 2012
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01068821
Brief Title
Trendelenburg's Slide Prevention Study
Acronym
SPS
Official Title
Randomized Controlled Trial Comparing Commonly Used Techniques to Prevent Slippage During Steep Trendelenburg's Position
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Misadventure During Surgical Operation, Postoperative Complications
Keywords
Slide, Trendelenburg's position, Postoperative, neurologic complaints

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Egg crate foam mattress
Arm Type
Active Comparator
Arm 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).
Arm Title
Gel pad
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Gel pad
Other Intervention Name(s)
Gel Pad:, Allen Medical
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Egg crate foam mattress
Other Intervention Name(s)
Pink Foam:, Kendall Company, Ref# 31163457
Intervention Description
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.
Primary Outcome Measure Information:
Title
Amount of Patient Movement on the Operating Room Table
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
Secondary Outcome Measure Information:
Title
Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E Wechter, MD, MPH
Organizational Affiliation
Mayo Clinic, Baptist Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32233
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20471916
Citation
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.
Results Reference
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Trendelenburg's Slide Prevention Study

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