Clinical trial NCT01068821: Trendelenburg's Slide Prevention Study
Official title: Randomized Controlled Trial Comparing Commonly Used Techniques to Prevent Slippage During Steep Trendelenburg's Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Misadventure During Surgical Operation
Postoperative Complications
Keywords: Slide
Trendelenburg's position
Postoperative
neurologic complaints
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-02-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Amount of Patient Movement on the Operating Room Table
timeFrame: About 150 minutes after start of surgery
Secondary outcomes:
measure: Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery
timeFrame: postoperative day 1 and postoperative week 3-8
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic, Baptist Medical Center
name: Mary E Wechter, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.