Trendelenburg's Slide Prevention Study

Not Applicable

Completed

• Conditions: Misadventure During Surgical Operation; Postoperative Complications
• Interventions: Other: Egg crate foam mattress; Other: Gel pad

• Registration Number: NCT01068821
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2010-02-12
• Study First Submitted QC: 2010-02-12
• Study First Posted: 2010-02-15
• Study Start: 2010-03
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2011-08-15
• Status Verified: 2012-04
• Results First Submitted QC: 2012-04-16
• Last Update Submitted: 2012-04-16
• Results First Posted: 2012-05-15
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

• Patients with intolerance of Trendelenburg's position
• Patients whose surgery are converted to laparotomy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Egg crate foam mattress	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).
Gel pad	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States