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Completed

NCT Number: NCT01068821

Trendelenburg's Slide Prevention Study

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.

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Key information

Conditions

Misadventure During Surgical Operation Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Gel Pad:, Allen Medical

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.

Other names: Pink Foam:, Kendall Company, Ref# 31163457

Primary outcomes

  1. Amount of Patient Movement on the Operating Room Table

    Time frame: 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 outcomes

  1. Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Randomized Controlled Trial Comparing Commonly Used Techniques to Prevent Slippage During Steep Trendelenburg's Position

Acronym: SPS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 15, 2010
Registry last updated
May 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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