Misadventure During Surgical OperationSPSNCT01068821

Trendelenburg's Slide Prevention Study

A study testing Gel pad and Egg crate foam mattress in people with Misadventure During Surgical Operation and Postoperative Complications, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Misadventure During Surgical Operation, Postoperative Complications
What is being tested?: Gel pad and Egg crate foam mattress
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Mar 2010to Aug 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic Florida
Jacksonville, Florida, 32233

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Misadventure During Surgical Operation, Postoperative Complications
Being tested: Gel pad, Egg crate foam mattress
Keywords: Slide, Trendelenburg's position, Postoperative, neurologic complaints
Medical subject headings: Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gel padOther
Also called Gel Pad:, Allen Medical
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.
Egg crate foam mattressOther
Also called Pink Foam:, Kendall Company, Ref# 31163457
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.

Study groups in NCT01068821
Study group	Role	What they receive
Egg crate foam mattress	Active comparator	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). Receives: Other: Egg crate foam mattress
Gel pad	Active comparator	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). Receives: Other: Gel pad

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: About 150 minutes after start of surgery

Secondary outcomes (1)

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.
Measured: postoperative day 1 and postoperative week 3-8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Aug 2011

First posted15 Feb 2010 (estimated)
Study startMar 2010
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Misadventure During Surgical OperationStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01068821
Sponsor's protocol ID: 09-000685-01
Acronym: SPS
Status last verified: Apr 2012
First submitted: 12 Feb 2010
Last updated: 15 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 20471916

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial Comparing Commonly Used Techniques to Prevent Slippage During Steep Trendelenburg's Position
ClinicalTrials.gov ID: NCT01068821
Acronym / sponsor ID: SPS / 09-000685-01
Conditions: Misadventure During Surgical Operation, Postoperative Complications
Keywords: Slide, Trendelenburg's position, Postoperative, neurologic complaints
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: Mar 2010
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 15 Feb 2010 (estimated)
Results: Posted 15 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Egg crate foam mattress	Active comparator	Other: Egg crate foam mattressPatients 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	Active comparator	Other: Gel padPatients 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).

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gel padAlso: Gel Pad:, Allen MedicalA 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	Gel pad
Egg crate foam mattressAlso: Pink Foam:, Kendall Company, Ref# 31163457An 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	Egg crate foam mattress

Primary outcome

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.

1 secondary outcome

Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery
Time frame: postoperative day 1 and postoperative week 3-8

Results and safety

Results posted to the registry on 15 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Egg Crate Foam Mattress	31	30
Gel Pad	29	29

Primary outcome: Amount of Patient Movement on the Operating Room Table

Time frame: About 150 minutes after start of surgery. Mean (Standard Deviation). Unit: centimeters

Measure	Egg Crate Foam Mattress n = 30	Gel Pad n = 29
Value	3.2 (1.9)	4.5 (4.0)

Egg Crate Foam Mattress vs Gel Pad: p = 0.1, t-test, 2 sided

Population analysed: Study size calculation was performed for 80% power, and p=0.05

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Participants were followed from randomization until final chart review at study end: Mean follow up surveillance of 344.9 days (SD 116.2). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Egg Crate Foam Mattress	0 of 30 (0%)	0 of 30 (0%)	Not reported
Gel Pad	0 of 29 (0%)	0 of 29 (0%)	Not reported

Limitations and caveats (from the sponsor): Evaluation of postoperative outcomes was non-systematic using chart review for all participants except for one participant whose identity was not listed on data abstraction sheet.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20471916Klauschie 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary E Wechter, MD, MPH principal investigator

Mayo Clinic, Baptist Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Gel pad and Egg crate foam mattress in people with Misadventure During Surgical Operation and Postoperative Complications, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of Patient Movement on the Operating Room Table (time frame: About 150 minutes after start of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01068821, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.