Misadventure During Surgical Operation, Postoperative Complications
Conditions
Keywords
Slide, Trendelenburg's position, Postoperative, neurologic complaints
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.
Interventions
OTHERGel 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.
OTHEREgg 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Patient Movement on the Operating Room Table | About 150 minutes after start of surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery | postoperative day 1 and postoperative week 3-8 | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 31 |
| 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). | 29 |
| Total | 60 |
Baseline characteristics
| Characteristic | Gel Pad | Egg Crate Foam Mattress | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 8 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 23 Participants | 45 Participants |
| Age Continuous | 53.6 years STANDARD_DEVIATION 12.7 | 55.5 years STANDARD_DEVIATION 11.8 | 54.6 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment United States | 29 participants | 31 participants | 60 participants |
| Sex: Female, Male Female | 29 Participants | 31 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 29 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 |
Outcome results
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.
Time frame: About 150 minutes after start of surgery
Population: Study size calculation was performed for 80% power, and p=0.05
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Egg Crate Foam Mattress | Amount of Patient Movement on the Operating Room Table | 3.2 centimeters | Standard Deviation 1.9 |
| Gel Pad | Amount of Patient Movement on the Operating Room Table | 4.5 centimeters | Standard Deviation 4 |
Comparison: 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.p-value: 0.1t-test, 2 sided
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.
Time frame: postoperative day 1 and postoperative week 3-8
Population: Participants were analyzed per protocol if they returned for postoperative followup (59 of 60 were analyzed)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Egg Crate Foam Mattress | Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery | 0 participants | 0 |
| Gel Pad | Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery | 3 participants | 0.19 |
Comparison: Fischer's exact test, significance defined as p\<0.05p-value: 0.5Fisher Exact