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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Egg crate foam mattress | Active Comparator | 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). |
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| Gel pad | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gel pad | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | About 150 minutes after start of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary E Wechter, MD, MPH | Mayo Clinic, Baptist Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20471916 | Background | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Gel Pad |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Study size calculation was performed for 80% power, and p=0.05 | Posted | Mean | Standard Deviation | centimeters | About 150 minutes after start of surgery |
|
Participants were followed from randomization until final chart review at study end: Mean follow up surveillance of 344.9 days (SD 116.2)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary Ellen Wechter | Mayo Clinic, Florida | 904 412 7351 | wechter.mary@mayo.edu |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
|
| Egg crate foam mattress | Other | 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. |
|
|
| postoperative day 1 and postoperative week 3-8 |
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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Gel Pad | Patient positioned on gel pad during surgery |
|
|
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| Secondary | 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. | Participants were analyzed per protocol if they returned for postoperative followup (59 of 60 were analyzed) | Posted | Number | participants | postoperative day 1 and postoperative week 3-8 |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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). | 0 | 29 | 0 | 29 |
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