NCT04427085

Brief Summary

This study aims to compare the change of optic nerve sheath diameter in obese and non-obese patients undergoing laparoscopic gynecological surgery in a steep Trendelenburg position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 22, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 3, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2022

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

1.8 years

First QC Date

April 22, 2020

Last Update Submit

June 24, 2024

Conditions

Optic Nerve Sheath Diameter

Outcome Measures

Primary Outcomes (1)

  • Optic nerve sheath diameter

    Using ultrasonography, optic nerve sheath diameter is measured.

    30 minutes after pneuroperitoneum in the Trendelenburg position

Secondary Outcomes (9)

  • Optic nerve sheath diameter

    15 minutes after pneuroperitoneum in the Trendelenburg position

  • Optic nerve sheath diameter

    60 minutes after pneuroperitoneum in the Trendelenburg position

  • Optic nerve sheath diameter

    10 minutes after release of pneumoperitoneum and return to the supine position

  • Optic nerve sheath diameter

    At 1 hour after completion of surgery

  • Optic nerve sheath diameter

    At 24 hours after completion of surgery

  • +4 more secondary outcomes

Study Arms (2)

Obese group

EXPERIMENTAL

body mass index≥ 30 kg/m2

Other: Ultrasound assessment of optic nerve sheath diameter

Non-obese group

ACTIVE COMPARATOR

BMI \< 30 kg/m2

Other: Ultrasound assessment of optic nerve sheath diameter

Interventions

Ultrasound assessment of optic nerve sheath diameterOTHER

Using ultrasonography, optic nerve sheath diameter is measured during perioperative period.

Non-obese groupObese group

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing laparoscopic gynecological surgery

You may not qualify if:

  • Ophthalmic diseases
  • Previous history of ophthalmic surgery.
  • Neurological disorders
  • History of head surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 22, 2020

First Posted

June 11, 2020

Study Start

August 3, 2020

Primary Completion

May 23, 2022

Study Completion

May 24, 2022

Last Updated

June 26, 2024

Record last verified: 2024-06

Locations

KR(1)