LaparoscopyNCT03589404
Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation
A study testing rso2 in people with Laparoscopy and Abdominal Wall, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
During laparoscopic surgery, the abdomen is inflated with carbon dioxide for abdominal imaging and increased intraabdominal pressure affects intraabdominal structures and abdominal wall. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopy, Abdominal Wall
- What is being tested?
- rso2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2018to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- Underwent laparoscopic cholecystectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16110
About this study
Official title: 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.
Read the detailed description
The investigators aimed to investigate the effects of pneumoperitoneum administered during laparoscopic cholecystectomy on abdominal wall oxygenation and postoperative pain scores.
- Conditions
- Laparoscopy, Abdominal Wall
- Being tested
- rso2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rso2Device
Also called abdominal wall tissue oxygenation
The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: rso2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: perioperative
Secondary outcomes (2)
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)
Measured: Postoperative 24 hours
analgesic use
analgesic use
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start15 Jul 2018
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, cohort,double blind
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Korgün Ökmen, M.D, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589404
- Sponsor's protocol ID
- 2011-KAEK-25 2018/04-24
- Status last verified
- Dec 2019
- First submitted
- 5 Jul 2018
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation on Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03589404
- Acronym / sponsor ID
- 2011-KAEK-25 2018/04-24
- Conditions
- Laparoscopy, Abdominal Wall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, cohort,double blind
| Arm | Type | Receives |
|---|---|---|
| rso2 | Experimental | Device: rso2The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- Underwent laparoscopic cholecystectomy
Key exclusion criteria (8 listed)
- Previous surgeon surgeon
- Local anesthetic allergy,
- Bleeding is a diathesis disorder
- Mental impairment,
- Allergic to the drugs used,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rso2Also: abdominal wall tissue oxygenationThe 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 |
Primary outcome
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
2 secondary outcomes
Visual Analog Scale
Time frame: Postoperative 24 hours
analgesic use
Time frame: Postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Korgün Ökmen, M.D principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rso2 in people with Laparoscopy and Abdominal Wall, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rso2 (time frame: perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.