NCT03589404

Brief Summary

During laparoscopic surgery, the abdomen is inflated with carbon dioxide for abdominal imaging and increased intraabdominal pressure affects intraabdominal structures and abdominal wall.

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 Jul 2018

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

July 5, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

July 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

December 18, 2019

Status Verified

December 1, 2019

Enrollment Period

1.3 years

First QC Date

July 5, 2018

Last Update Submit

December 17, 2019

Conditions

LaparoscopyAbdominal Wall

Outcome Measures

Primary Outcomes (1)

  • rso2

    The regional oxymetry probe (Medtronic Quick Assist INVOS™ (In-Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter) will be placed in the abdominal region of the umbilicus in the middle clavicular line

    perioperative

Secondary Outcomes (2)

  • Visual Analog Scale

    Postoperative 24 hours

  • analgesic use

    Postoperative 24 hours

Study Arms (1)

rso2

EXPERIMENTAL

The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.

Device: rso2

Interventions

rso2DEVICE

The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.

Also known as: abdominal wall tissue oxygenation
rso2

Eligibility Criteria

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

You may qualify if:

  • Patients who were in the American Society of Anesthesiologists (ASA) I-III class
  • Underwent laparoscopic cholecystectomy

You may not qualify if:

  • Previous surgeon surgeon
  • Local anesthetic allergy,
  • Bleeding is a diathesis disorder
  • Mental impairment,
  • Allergic to the drugs used,
  • Patients who are not reluctant to participate in the study,
  • Presence of infection in the block area,
  • Patients whose body mass index is over 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16110, Turkey (Türkiye)

Location

Study Officials

  • Korgün Ökmen, M.D

    Bursa Yuksek Ihtisas Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
investigator
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: prospective, cohort,double blind
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 17, 2018

Study Start

July 15, 2018

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

December 18, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)