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Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation

Primary Purpose

Laparoscopy, Abdominal Wall

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
rso2
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Laparoscopy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Bursa Yuksek Ihtisas Training and Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rso2

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual Analog Scale
Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0=no pain, 10=intolerable pain)
analgesic use
analgesic use

Full Information

First Posted
July 5, 2018
Last Updated
December 17, 2019
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03589404
Brief Title
Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation
Official Title
Investigation of the Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation on Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The investigators aimed to investigate the effects of pneumoperitoneum administered during laparoscopic cholecystectomy on abdominal wall oxygenation and postoperative pain scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopy, Abdominal Wall

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective, cohort,double blind
Masking
None (Open Label)
Masking Description
investigator
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rso2
Arm Type
Experimental
Arm Description
The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.
Intervention Type
Device
Intervention Name(s)
rso2
Other Intervention Name(s)
abdominal wall tissue oxygenation
Intervention Description
The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.
Primary Outcome Measure Information:
Title
rso2
Description
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
Time Frame
perioperative
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Description
Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0=no pain, 10=intolerable pain)
Time Frame
Postoperative 24 hours
Title
analgesic use
Description
analgesic use
Time Frame
Postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who were in the American Society of Anesthesiologists (ASA) I-III class Underwent laparoscopic cholecystectomy Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Korgün Ökmen, M.D
Organizational Affiliation
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bursa Yuksek Ihtisas Training and Research Hospital
City
Bursa
ZIP/Postal Code
16110
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation

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