Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03589404
Recruitment Status : Not yet recruiting
First Posted : July 17, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Korgün Ökmen, Bursa Yüksek İhtisas Education and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Laparoscopy Abdominal Wall Device: rso2 Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: prospective, cohort,double blind
Masking: None (Open Label)
Masking Description: investigator
Primary Purpose: Diagnostic
Official Title: Investigation of the Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation on Laparoscopic Cholecystectomy
Estimated Study Start Date : July 15, 2018
Estimated Primary Completion Date : September 15, 2018
Estimated Study Completion Date : September 15, 2018

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 Name: abdominal wall tissue oxygenation




Primary Outcome Measures :
  1. rso2 [ Time Frame: perioperative ]
    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 :
  1. Visual Analog Scale [ Time Frame: Postoperative 24 hours ]
    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)

  2. analgesic use [ Time Frame: Postoperative 24 hours ]
    analgesic use



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589404


Contacts
Layout table for location contacts
Contact: korgün Ökmen, M.D 05057081021 korgunokmen@gmail.com
Contact: Burcu Metin Ökmen, M.D 05057081020 burcumetinokmen@gmail.com

Sponsors and Collaborators
Bursa Yüksek İhtisas Education and Research Hospital
Investigators
Layout table for investigator information
Principal Investigator: Korgün Ökmen, M.D University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Layout table for additonal information
Responsible Party: Korgün Ökmen, Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03589404     History of Changes
Other Study ID Numbers: 2011-KAEK-25 2018/04-24
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases