Colon DiseaseNCT04428229
Optic Nerve Sheath Diameter in Laparoscopic Surgeries During Trendelenburg Position
An observational study of Colon Disease and Gynecologic Disease, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
It is difficult to measure the several levels of intracranial pressure during abdominal surgery, and direct monitoring with intracranial devices is often impossible. Measurement of optic nerve sheath diameter (ONSD) via ultrasonography has been developed as an alternative method for evaluating intracranial pressure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Disease, Gynecologic Disease
- What is being tested?
- Optic nerve sheath diameter
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2020to 30 Apr 2021
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Laparoscopic colon and gynecologic surgery patients aged between 18-75 years with ASA I and ASA II status will be included in this randomized prospective study.
Who may be able to join
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for laparoscopic colon and gynecologic surgeries under general anesthesia
Who cannot join
- use of beta blocker or diuretic drugs
- severe heart failure
- diabetes with ocular or neurologic complications
- history of cardiac, eye, intracranial, and thoracic surgery
- history of hydrocephalus, glocoma, intracranial tumor, cerebrovascular disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
About this study
Official title: The Evaluation of Optic Nerve Sheath Diameter in Patients Underwent Laparoscopic Colon and Gynecologic Surgeries During Trendelenburg Position.
It is difficult to measure the several levels of intracranial pressure during abdominal surgery, and direct monitoring with intracranial devices is often impossible. Measurement of optic nerve sheath diameter (ONSD) via ultrasonography has been developed as an alternative method for evaluating intracranial pressure. Increased intracranial pressure may cause in expanding of the optic nerve sheath and may increase the diameter. Therefore, measuring the diameter of the optic nerve sheath via ultrasonography is considered as a non-invasive, easy-to-apply and reliable method to evaluate intracranial pressure.
Read the detailed description
The peritoneum is inflated with carbon dioxide (insufflation) and head-down position is performed (Trendelenburg) during laparoscopic colon and gynecologic surgeries. Intracranial pressure (ICP) may be affected by positive intraabdominal pressure due to pneumoperitoneum. The Trendelenburg position (usually at a degree of 25-400) causes increasing in the pressure of cerebrospinal fluid during surgery. Therefore, cerebral edema and an increasing in ICP may occur. It is difficult to measure the several levels of intracranial pressure during abdominal surgery, and direct monitoring with intracranial devices is often impossible. Measurement of optic nerve sheath diameter (ONSD) via ultrasonography has been developed as an alternative method for evaluating intracranial pressure. The optic nerve is an extension of the central nervous system, surrounded by cerebrospinal fluid (CSF) and continues with the nerve sheath. Increased intracranial pressure may cause in expanding of the optic nerve sheath and may increase the diameter. Therefore, measuring the diameter of the optic nerve sheath via ultrasonography is considered as a non-invasive, easy-to-apply and reliable method to evaluate intracranial pressure.
In this study, we aimed to evaluate the changes of optic nerve sheath diameter in patients who will undergo laparoscopic colon and gynecologic surgery during trendelenburg position. Our primary goal is to compare the optic nerve sheath diameters via ultrasonography, and our secondary aim is to evaluate the effect of this change on intracranial pressure.
- Conditions
- Colon Disease, Gynecologic Disease
- Being tested
- Optic nerve sheath diameter
- Keywords
- Trendelenburg position, Optic nerve sheath diameter, Colon surgery, Gynecologic surgery
- Medical subject headings
- Colonic Diseases, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic nerve sheath diameterOther
Pre and post-trendelenburg optic nerve sheath diameter will be measured
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter
Pre and post-trendelenburg diameters of optic nerve sheath
Measured: Change from baseline optic nerve sheath diameter at 10 mins and 60 mins after trendelenburg. And 10 minutes after the re-neutral position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start15 Jul 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428229
- Sponsor's protocol ID
- Medipol Hospital 14
- Status last verified
- May 2021
- First submitted
- 9 Jun 2020
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not plan to share IPD data
Publications
Robba C, Cardim D, Donnelly J, Bertuccio A, Bacigaluppi S, Bragazzi N, Cabella B, Liu X, Matta B, Lattuada M, Czosnyka M. Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using different non-invasive methods. Br J Anaesth. 2016 Dec;117(6):783-791. doi: 10.1093/bja/aew356.
PubMed 27956677Chen K, Wang L, Wang Q, Liu X, Lu Y, Li Y, Wong GTC. Effects of pneumoperitoneum and steep Trendelenburg position on cerebral hemodynamics during robotic-assisted laparoscopic radical prostatectomy: A randomized controlled study. Medicine (Baltimore). 2019 May;98(21):e15794. doi: 10.1097/MD.0000000000015794.
PubMed 31124975Colombo R, Agarossi A, Borghi B, Ottolina D, Bergomi P, Ballone E, Minari C, Della Porta V, Menozzi E, Figini S, Fossali T, Catena E. The effect of prolonged steep head-down laparoscopy on the optical nerve sheath diameter. J Clin Monit Comput. 2020 Dec;34(6):1295-1302. doi: 10.1007/s10877-019-00418-5. Epub 2019 Nov 5.
PubMed 31691148
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Optic Nerve Sheath Diameter in Patients Underwent Laparoscopic Colon and Gynecologic Surgeries During Trendelenburg Position.
- ClinicalTrials.gov ID
- NCT04428229
- Acronym / sponsor ID
- Medipol Hospital 14
- Conditions
- Colon Disease, Gynecologic Disease
- Keywords
- Trendelenburg position, Optic nerve sheath diameter, Colon surgery, Gynecologic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 11 Jun 2020 (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.
It is difficult to measure the several levels of intracranial pressure during abdominal surgery, and direct monitoring with intracranial devices is often impossible. Measurement of optic nerve sheath diameter (ONSD) via ultrasonography has been developed as an alternative method for evaluating intracranial pressure. Increased intracranial pressure may cause in expanding of the optic nerve sheath and may increase the diameter. Therefore, measuring the diameter of the optic nerve sheath via ultrasonography is considered as a non-invasive, easy-to-apply and reliable method to evaluate intracranial pressure.
Detailed description
The peritoneum is inflated with carbon dioxide (insufflation) and head-down position is performed (Trendelenburg) during laparoscopic colon and gynecologic surgeries. Intracranial pressure (ICP) may be affected by positive intraabdominal pressure due to pneumoperitoneum. The Trendelenburg position (usually at a degree of 25-400) causes increasing in the pressure of cerebrospinal fluid during surgery. Therefore, cerebral edema and an increasing in ICP may occur. It is difficult to measure the several levels of intracranial pressure during abdominal surgery, and direct monitoring with intracranial devices is often impossible. Measurement of optic nerve sheath diameter (ONSD) via ultrasonography has been developed as an alternative method for evaluating intracranial pressure. The optic nerve is an extension of the central nervous system, surrounded by cerebrospinal fluid (CSF) and continues with the nerve sheath. Increased intracranial pressure may cause in expanding of the optic nerve sheath and may increase the diameter. Therefore, measuring the diameter of the optic nerve sheath via ultrasonography is considered as a non-invasive, easy-to-apply and reliable method to evaluate intracranial pressure.
In this study, we aimed to evaluate the changes of optic nerve sheath diameter in patients who will undergo laparoscopic colon and gynecologic surgery during trendelenburg position. Our primary goal is to compare the optic nerve sheath diameters via ultrasonography, and our secondary aim is to evaluate the effect of this change on intracranial pressure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Laparoscopic colon and gynecologic surgery patients aged between 18-75 years with ASA I and ASA II status will be included in this randomized prospective study.
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for laparoscopic colon and gynecologic surgeries under general anesthesia
Key exclusion criteria (5 listed)
- use of beta blocker or diuretic drugs
- severe heart failure
- diabetes with ocular or neurologic complications
- history of cardiac, eye, intracranial, and thoracic surgery
- history of hydrocephalus, glocoma, intracranial tumor, cerebrovascular disease
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 |
|---|---|---|
| Optic nerve sheath diameterPre and post-trendelenburg optic nerve sheath diameter will be measured | Other | – |
Primary outcome
Optic nerve sheath diameter
Time frame: Change from baseline optic nerve sheath diameter at 10 mins and 60 mins after trendelenburg. And 10 minutes after the re-neutral position
Pre and post-trendelenburg diameters of optic nerve sheath
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 20 May 2021.
- Background: PubMed 27956677Robba C, Cardim D, Donnelly J, Bertuccio A, Bacigaluppi S, Bragazzi N, Cabella B, Liu X, Matta B, Lattuada M, Czosnyka M. Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using different non-invasive methods. Br J Anaesth. 2016 Dec;117(6):783-791. doi: 10.1093/bja/aew356.
- Background: PubMed 31124975Chen K, Wang L, Wang Q, Liu X, Lu Y, Li Y, Wong GTC. Effects of pneumoperitoneum and steep Trendelenburg position on cerebral hemodynamics during robotic-assisted laparoscopic radical prostatectomy: A randomized controlled study. Medicine (Baltimore). 2019 May;98(21):e15794. doi: 10.1097/MD.0000000000015794.
- Background: PubMed 31691148Colombo R, Agarossi A, Borghi B, Ottolina D, Bergomi P, Ballone E, Minari C, Della Porta V, Menozzi E, Figini S, Fossali T, Catena E. The effect of prolonged steep head-down laparoscopy on the optical nerve sheath diameter. J Clin Monit Comput. 2020 Dec;34(6):1295-1302. doi: 10.1007/s10877-019-00418-5. Epub 2019 Nov 5.
- Individual participant dataSharing planned: No. We will not plan to share IPD data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Disease and Gynecologic Disease, run by Medipol University 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 5 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 20 May 2021. 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?
Optic nerve sheath diameter (time frame: Change from baseline optic nerve sheath diameter at 10 mins and 60 mins after trendelenburg. And 10 minutes after the re-neutral position). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04428229, which also lists 3 linked publications.
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 20 May 2021.