NCT02728999

Brief 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 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2016

Completed
Last Updated

October 4, 2024

Status Verified

January 1, 2018

Enrollment Period

3.1 years

First QC Date

March 1, 2016

Last Update Submit

October 2, 2024

Conditions

Benign Female Reproductive System Neoplasm

Keywords

Trendelenburg positionRobotic assisted gynecologic proceduresbenign gynecologic conditions

Outcome Measures

Primary Outcomes (1)

  • • 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)

    0-240 minutes

Secondary Outcomes (9)

  • Cardiovascular Outcomes- Heart rate

    0-240 minutes

  • Respiratory Parameter- arterial CO2

    0-240 minutes

  • Respiratory Outcomes- End Tidal CO2

    0-240 minutes

  • Respiratory Outcomes- Peak Airway Pressure

    0-240 minutes

  • Cardiovascular Outcomes- Mean arterial Pressure

    0-240 minutes

  • +4 more secondary outcomes

Study Arms (2)

Group A

OTHER

Steep Trendelenburg

Procedure: Steep Trendelenburg

Group B

EXPERIMENTAL

Decreased Trendelenburg

Procedure: Decreased Trendelenburg

Interventions

Steep TrendelenburgPROCEDURE

•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.

Also known as: Arterial Line in Wrist
Group A
Decreased TrendelenburgPROCEDURE

•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.

Also known as: Arterial Line in Wrist
Group B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Interventions

Vascular Access Devices

Intervention Hierarchy (Ancestors)

CathetersEquipment and Supplies

Study Officials

  • Kirsten Sasaki, MD

    Advocate Lutheran General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2016

First Posted

April 6, 2016

Study Start

June 1, 2013

Primary Completion

July 20, 2016

Study Completion

July 20, 2016

Last Updated

October 4, 2024

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

Manuscript and conference presentation

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Data will be available starting 2/2018 for 6 months
Access Criteria
Any person that requests analyzed data.

Locations

US(1)