Trendelenburg's Slide Prevention Study (SPS)

Mayo Clinic

Status: Completed

Conditions: Postoperative Complications; Misadventure During Surgical Operation

Treatments: Other: Gel pad; Other: Egg crate foam mattress

Study type: Interventional

Funder types: Other

Identifiers

NCT01068821

09-000685-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Egg crate foam mattress

Active Comparator group

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).

Treatment:

Other: Egg crate foam mattress

Gel pad

Active Comparator group

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).

Treatment:

Other: Gel pad