Vaginal SurgeryNCT03573557
Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface
A study testing Pink Pad, Bean Bag and Gel Pad in people with Vaginal Surgery and Laparoscopic Surgery, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
To identify the best surface to minimize the risk of intra-operative slipping when placed in Trendelenburg position. The outcomes of interest are to minimize the amount of movement from predefined anatomic landmarks and maximize the ease of performing the intended surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Surgery, Laparoscopic Surgery
- What is being tested?
- Pink Pad, Bean Bag and Gel Pad
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2018to 17 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo major laparoscopic or vaginal surgery by participating physicians at University Hospital Cleveland Medical Center
- Patients must not be pregnant
Who cannot join
- Pregnancy
- Patients unable to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
To identify the best surface to minimize the risk of intra-operative slipping when placed in Trendelenburg position. The outcomes of interest are to minimize the amount of movement from predefined anatomic landmarks and maximize the ease of performing the intended surgery. The study consists of performing a randomized trial comparing 3 common anti-slip surfaces to determine which surface provides the best result in terms of safety and cost.
Read the detailed description
Laparoscopic surgery has become increasingly important in the drive to reduce patient morbidity. The introduction of robotic surgery has only served to accelerate this trend by allowing more complex surgeries to be performed using a minimally invasive technique. A key requirement of any minimally invasive gynecologic procedure is adequate visualization of the pelvis. This necessitates moving the bowel into the upper abdomen which is facilitated by placing patients in the Trendelenburg position. Steep Trendelenburg in the range of 30-40 degrees has historically been referenced as necessary for adequate visualization, but modern studies have found 16-28 degrees to be adequate. In practice, most physicians obtain the maximum Trendelenburg available as increasingly complex surgeries are attempted using minimally invasive techniques.
- Conditions
- Vaginal Surgery, Laparoscopic Surgery
- Being tested
- Pink Pad, Bean Bag, Gel Pad
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pink PadDevice
Pink Pad made by Xodus Medical Inc. used for patients in steep Trendelenburg position during surgery.
Bean BagDevice
Vac-Pac Bean Bag made by Olympic used for patients in steep Trendelenburg position during surgery.
Gel PadDevice
Gel Pad used for patients in steep Trendelenburg position during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pink Pad | Active comparator | The Pink Pad will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg to determine how much slipping is happening during the procedure. Receives: Device: Pink Pad |
| Bean Bag | Active comparator | The Bean Bag will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg to determine how much slipping is happening during the procedure. Receives: Device: Bean Bag |
| Gel Pad | Active comparator | The Gel Pad will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg determine how much slipping is happening during the procedure. Receives: Device: Gel Pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of displacement when in Trendelenburg
Normal amount of displacement when place in Trendelenburg
Measured: 1 day
Secondary outcomes (10)
Cost of device
How cost effective is each surface
Measured: 1 day
Rank of ease of use by physician
Surgeon will rate how the surface interferes with surgery
Measured: 1 day
Number of adverse events
Count of adverse events per surface
Measured: 1 day
Erythema score
Erythema score per surface graded by skin redness
Measured: 1 day
Patient BMI
Influence of patient BMI on displacement per anti-slip surface
Measured: 1 day
Patient age
Influence of patient age on displacement per anti-slip surface
Measured: 1 day
Patient weight
Influence of patient weight on displacement per anti-slip surface
Measured: 1 day
Patient height
Influence of patient height on displacement per anti-slip surface
Measured: 1 day
Patient Hip circumference
Influence of patient hip circumference on displacement per anti-slip surface
Measured: 1 day
Patient Waist circumference
Influence of patient waist circumference on displacement per anti-slip surface
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start5 Jun 2018
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal SurgeryStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherif El-Nashar, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573557
- Sponsor's protocol ID
- CASE4817
- Status last verified
- Mar 2022
- First submitted
- 15 Jun 2018
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface
- ClinicalTrials.gov ID
- NCT03573557
- Acronym / sponsor ID
- CASE4817
- Conditions
- Vaginal Surgery, Laparoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify the best surface to minimize the risk of intra-operative slipping when placed in Trendelenburg position. The outcomes of interest are to minimize the amount of movement from predefined anatomic landmarks and maximize the ease of performing the intended surgery. The study consists of performing a randomized trial comparing 3 common anti-slip surfaces to determine which surface provides the best result in terms of safety and cost.
Detailed description
Laparoscopic surgery has become increasingly important in the drive to reduce patient morbidity. The introduction of robotic surgery has only served to accelerate this trend by allowing more complex surgeries to be performed using a minimally invasive technique. A key requirement of any minimally invasive gynecologic procedure is adequate visualization of the pelvis. This necessitates moving the bowel into the upper abdomen which is facilitated by placing patients in the Trendelenburg position. Steep Trendelenburg in the range of 30-40 degrees has historically been referenced as necessary for adequate visualization, but modern studies have found 16-28 degrees to be adequate. In practice, most physicians obtain the maximum Trendelenburg available as increasingly complex surgeries are attempted using minimally invasive techniques.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pink Pad | Active comparator | Device: Pink PadThe Pink Pad will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg to determine how much slipping is happening during the procedure. |
| Bean Bag | Active comparator | Device: Bean BagThe Bean Bag will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg to determine how much slipping is happening during the procedure. |
| Gel Pad | Active comparator | Device: Gel PadThe Gel Pad will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg determine how much slipping is happening during the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled to undergo major laparoscopic or vaginal surgery by participating physicians at University Hospital Cleveland Medical Center
- Patients must not be pregnant
Key exclusion criteria (2 listed)
- Pregnancy
- Patients unable to give consent
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 |
|---|---|---|
| Pink PadPink Pad made by Xodus Medical Inc. used for patients in steep Trendelenburg position during surgery. | Device | Pink Pad |
| Bean BagVac-Pac Bean Bag made by Olympic used for patients in steep Trendelenburg position during surgery. | Device | Bean Bag |
| Gel PadGel Pad used for patients in steep Trendelenburg position during surgery. | Device | Gel Pad |
Primary outcome
Length of displacement when in Trendelenburg
Time frame: 1 day
Normal amount of displacement when place in Trendelenburg
10 secondary outcomes
Cost of device
Time frame: 1 day
Rank of ease of use by physician
Time frame: 1 day
Number of adverse events
Time frame: 1 day
Erythema score
Time frame: 1 day
Patient BMI
Time frame: 1 day
Patient age
Time frame: 1 day
Patient weight
Time frame: 1 day
Patient height
Time frame: 1 day
Patient Hip circumference
Time frame: 1 day
Patient Waist circumference
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
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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.
Sherif El-Nashar, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer 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 Pink Pad, Bean Bag and Gel Pad in people with Vaginal Surgery and Laparoscopic Surgery, run by Case Comprehensive Cancer Center 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 2 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 23 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of displacement when in Trendelenburg (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2022.