Benign Female Reproductive System NeoplasmNCT02728999
Does Less Trendelenburg Make a Difference in Robotic Assisted Gynecological Procedures?
A study testing Steep Trendelenburg and Decreased Trendelenburg in people with Benign Female Reproductive System Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Patient/Population: Women over the age of 18, who are not pregnant and are undergoing benign, robotic-assisted gynecologic procedures at Lutheran General Hospital. Intervention: Decreasing the angle of Trendelenburg for the procedure Control: Steep Trendelenburg, which is the usual standard of care, to the limit of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Benign Female Reproductive System Neoplasm
- What is being tested?
- Steep Trendelenburg and Decreased Trendelenburg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 20 Jul 2016
- 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
- all women at Lutheran General Hospital undergoing robotic-assisted benign gynecologic procedures and who agree to participate in the study.
- Women who are 18 years or older on the day of surgery.
- Patients with any co-morbidity or prior surgery, as long as they are cleared by their surgeon and anesthesia to undergo robotic-assisted surgery.
Who cannot join
- pregnant women
- Anyone who is less than 18 years old on the day of surgery.
- Anyone who does not have the capacity to make independent medical decisions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
About this study
Patient/Population: Women over the age of 18, who are not pregnant and are undergoing benign, robotic-assisted gynecologic procedures at Lutheran General Hospital.
Intervention: Decreasing the angle of Trendelenburg for the procedure Control: Steep Trendelenburg, which is the usual standard of care, to the limit of the operative bed, which is 30 degrees.
Outcome: Outcomes will include the mean angle of Trendelenburg in the experimental arm and the difference in Trendelenburg between the two arms. Additional outcomes included will be end tidal Carbon dioxide, peak airway pressure, mean arterial pressure, heart rate and arterial Carbon dioxide. Secondary outcomes will include operative time, blood loss and conversion to laparotomy.
Read the detailed description
For any patient undergoing robotic-assisted benign laparoscopic procedures at Lutheran General Hospital were eligible to participate. Each subject was randomized to steep or a decreased angle of Trendelenburg. While under anesthesia an arterial line would be placed to monitor vital signs. At specific time points throughout surgery, all vital signs were measured including End Tidal CO2, peak airway pressure, mean arterial pressure, heart rate and arterial CO2 as well as operative time, blood loss and conversion to laparotomy.
The arterial line was removed at the conclusion of the case, and all variables will be compared between the two cohorts.
- Being tested
- Steep Trendelenburg, Decreased Trendelenburg
- Keywords
- Trendelenburg position, Robotic assisted gynecologic procedures, benign gynecologic conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steep TrendelenburgProcedure or surgery
Also called Arterial Line in Wrist
•Subjects who undergo steep Trendelenburg will remain in 30 degrees of Trendelenburg, and the da Vinci robot will be docked.
After subjects are asleep an arterial line will be place in one wrist by the anesthesiologist. It will be removed at the conclusion of the procedure.
Decreased TrendelenburgProcedure or surgery
Also called Arterial Line in Wrist
•Subjects who undergo decreased Trendelenburg will be taken out of Trendelenburg to the minimal angle possible that enables adequate visualization, as determined by the primary surgeon, at which time robot will be docked.
After subjects are asleep an arterial line will be place in one wrist by the anesthesiologist. It will be removed at the conclusion of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Steep Trendelenburg Receives: Procedure: Steep Trendelenburg |
| Group B | Experimental | Decreased Trendelenburg Receives: Procedure: Decreased Trendelenburg |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Mean Angle of Trendelenburg during surgery (Degrees of the operative head down, measured by electronic angle meter) and the difference in the two arms
Measured using electronic Angle Meter from supine to Trendelenburg in degrees (0-30)
Measured: 0-240 minutes
Secondary outcomes (9)
Cardiovascular Outcomes- Heart rate
Heart rate (beats per minute) measured in beats per minute by anesthesiologist at the beginning of the case prior to insufflation, after insufflation, every 30 minutes while in Trendelenburg and at the end of the case.
Measured: 0-240 minutes
Respiratory Parameter- arterial CO2
Arterial CO2- Measured by taking an arterial blood gas from the arterial line by the anesthesiologist at the beginning of the case prior to insufflation, and then every hour while in Trendelenburg.
Measured: 0-240 minutes
Respiratory Outcomes- End Tidal CO2
End Tidal CO2 measured in mmHg by anesthesiologist at the beginning of the case prior to insufflation, after insufflation, every 30 minutes while in Trendelenburg and then at the end of the case.
Measured: 0-240 minutes
Respiratory Outcomes- Peak Airway Pressure
Peak Airway Pressure (mm Hg) measured in mmHg by anesthesiologist at the beginning of the case prior to insufflation, after insufflation, every 30 minutes while in Trendelenburg and then at the end of the case.
Measured: 0-240 minutes
Cardiovascular Outcomes- Mean arterial Pressure
Mean arterial pressure (mm hg) measured in mmHg by anesthesiologist at the beginning of the case prior to insufflation, after insufflation, every 30 minutes while in Trendelenburg and then at the end of the case.
Measured: 0-240 minutes
Operative Time
The operative time will be measured (minutes) from the time the robot was docked until it is undocked.
Measured: 1-240 minutes
Estimated Blood Loss
The blood loss (mL) will be measured by subtracting the irrigation fluid used from the fluid suctioned out during the procedure.
Measured: 0-240 minutes
Redocking of the robot
It will be recorded whether the robot required undocking, placement in greater Trendelenburg and redocking of the robot in order to complete the procedure.
Measured: 0-240 minutes
Conversion of surgical approach
It will be recorded whether the surgical approach was transitioned to traditional laparoscopy or laparotomy versus a robotic-assisted procedure as scheduled.
Measured: 0-240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startJun 2013
- Primary completion20 Jul 2016
- Study completion20 Jul 2016
Why it stopped: Did not want to expose additional subjects to Arterial Line placement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten Sasaki, MD, Principal investigator, Advocate Lutheran General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728999
- Sponsor's protocol ID
- AHCIRB 5589 Trendelenburg
- Status last verified
- Jan 2018
- First submitted
- 1 Mar 2016
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Manuscript and conference presentation
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Less Trendelenburg Make a Difference in Robotic Assisted Gynecological Procedures?
- ClinicalTrials.gov ID
- NCT02728999
- Acronym / sponsor ID
- AHCIRB 5589 Trendelenburg
- Keywords
- Trendelenburg position, Robotic assisted gynecologic procedures, benign gynecologic conditions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not want to expose additional subjects to Arterial Line placement
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 20 Jul 2016 (actual)
- Study completion
- 20 Jul 2016 (actual)
- First posted
- 6 Apr 2016 (estimated)
- 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.
Patient/Population: Women over the age of 18, who are not pregnant and are undergoing benign, robotic-assisted gynecologic procedures at Lutheran General Hospital.
Intervention: Decreasing the angle of Trendelenburg for the procedure Control: Steep Trendelenburg, which is the usual standard of care, to the limit of the operative bed, which is 30 degrees.
Outcome: Outcomes will include the mean angle of Trendelenburg in the experimental arm and the difference in Trendelenburg between the two arms. Additional outcomes included will be end tidal Carbon dioxide, peak airway pressure, mean arterial pressure, heart rate and arterial Carbon dioxide. Secondary outcomes will include operative time, blood loss and conversion to laparotomy.
Detailed description
For any patient undergoing robotic-assisted benign laparoscopic procedures at Lutheran General Hospital were eligible to participate. Each subject was randomized to steep or a decreased angle of Trendelenburg. While under anesthesia an arterial line would be placed to monitor vital signs. At specific time points throughout surgery, all vital signs were measured including End Tidal CO2, peak airway pressure, mean arterial pressure, heart rate and arterial CO2 as well as operative time, blood loss and conversion to laparotomy.
The arterial line was removed at the conclusion of the case, and all variables will be compared between the two cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Procedure: Steep TrendelenburgSteep Trendelenburg |
| Group B | Experimental | Procedure: Decreased TrendelenburgDecreased Trendelenburg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all women at Lutheran General Hospital undergoing robotic-assisted benign gynecologic procedures and who agree to participate in the study.
- Women who are 18 years or older on the day of surgery.
- Patients with any co-morbidity or prior surgery, as long as they are cleared by their surgeon and anesthesia to undergo robotic-assisted surgery.
Key exclusion criteria (3 listed)
- pregnant women
- Anyone who is less than 18 years old on the day of surgery.
- Anyone who does not have the capacity to make independent medical decisions.
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 |
|---|---|---|
| Steep TrendelenburgAlso: Arterial Line in Wrist•Subjects who undergo steep Trendelenburg will remain in 30 degrees of Trendelenburg, and the da Vinci robot will be docked. After subjects are asleep an arterial line will be place in one wrist by the anesthesiologist. It will be removed at the conclusion of the procedure. | Procedure or surgery | Group A |
| Decreased TrendelenburgAlso: Arterial Line in Wrist•Subjects who undergo decreased Trendelenburg will be taken out of Trendelenburg to the minimal angle possible that enables adequate visualization, as determined by the primary surgeon, at which time robot will be docked. After subjects are asleep an arterial line will be place in one wrist by the anesthesiologist. It will be removed at the conclusion of the procedure. | Procedure or surgery | Group B |
Primary outcome
• Mean Angle of Trendelenburg during surgery (Degrees of the operative head down, measured by electronic angle meter) and the difference in the two arms
Time frame: 0-240 minutes
Measured using electronic Angle Meter from supine to Trendelenburg in degrees (0-30)
9 secondary outcomes
Cardiovascular Outcomes- Heart rate
Time frame: 0-240 minutes
Respiratory Parameter- arterial CO2
Time frame: 0-240 minutes
Respiratory Outcomes- End Tidal CO2
Time frame: 0-240 minutes
Respiratory Outcomes- Peak Airway Pressure
Time frame: 0-240 minutes
Cardiovascular Outcomes- Mean arterial Pressure
Time frame: 0-240 minutes
Operative Time
Time frame: 1-240 minutes
Estimated Blood Loss
Time frame: 0-240 minutes
Redocking of the robot
Time frame: 0-240 minutes
Conversion of surgical approach
Time frame: 0-240 minutes
Results and safety
The study was stopped early (reason given: Did not want to expose additional subjects to Arterial Line placement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: Yes. Manuscript and conference presentation
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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.
Kirsten Sasaki, MD principal investigator
Advocate Lutheran General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steep Trendelenburg and Decreased Trendelenburg in people with Benign Female Reproductive System Neoplasm, run by Wake Forest University Health Sciences 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 3 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: stopped early, as of the sponsor's last update on 4 Oct 2024. 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 was stopped early (reason given: Did not want to expose additional subjects to Arterial Line placement). Results are not available in the source record.
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?
• Mean Angle of Trendelenburg during surgery (Degrees of the operative head down, measured by electronic angle meter) and the difference in the two arms (time frame: 0-240 minutes). 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 4 Oct 2024.