Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation

Investigation of the Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation on Laparoscopic Cholecystectomy

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

Study Overview

• Status: Completed
• Conditions: Laparoscopy; Abdominal Wall
• Intervention / Treatment: Device: rso2

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16110
    • Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rso2; 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; The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.; Other Names: abdominal wall tissue oxygenation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Postoperative 24 hours
analgesic use	analgesic use	Postoperative 24 hours

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Principal Investigator: Korgün Ökmen, M.D, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2018
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: 2011-KAEK-25 2018/04-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No