Post Operative PainNCT06132490
Intra-abdominal Pressure and Insufflator Effects in Robotic Surgery
A study testing Valveless Insufflator with 12 mmHg intra-abdominal pressure and Valveless Insufflator with 8 mmHg intra-abdominal pressure in people with Post Operative Pain and Hemodynamic Instability, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The main aim of this study is to compare the perioperative effects of different intra-abdominal pressures and different insufflators in patients undergoing robotic surgery at a 30-45 degree trendelenburg position. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Operative Pain, Hemodynamic Instability, Hypercapnia
- What is being tested?
- Valveless Insufflator with 12 mmHg intra-abdominal pressure and Valveless Insufflator with 8 mmHg intra-abdominal pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2022to 30 Dec 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective robotic surgery with intraabdominal insufflation and trendelenburg position (prostatectomy, hemicolectomy etc.)
- ASA (American Society of Anesthesiologists) Physical Status I-II-III
Who cannot join
- Patients without consent
- Emergency surgery
- Bleeding diathesis
- Pregnancy or lactation
- Prior history of major abdominal/pelvic surgery
- Chronic kidney disease
- Chronic opioid consumption for chronic pain
- Inability to communicate with the patient due to language barriers or mental status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Perioperative Effects of Intra-abdominal Pressure Created With Standard and Valveless Insufflators in Robotic Surgery
The main aim of this study is to compare the perioperative effects of different intra-abdominal pressures and different insufflators in patients undergoing robotic surgery at a 30-45 degree trendelenburg position.
Read the detailed description
Adult patients scheduled for robotic genitourinary or colorectal surgery are going to be enrolled in this study. Patients will be randomized in three groups. In group I, conventional insufflators will be used with 12 mmHg intra-abdominal pressure; in group II, valveless insufflators will be used with 12 mmHg intra-abdominal pressure and in group III, valveless insufflators will be used with 8 mmHg intra-abdominal pressure. Intraoperative data regarding airway pressures, lung compliance, hemodynamic parameters, arterial blood gas analysis, times of pressure loss and camera cleaning will be gathered. Each patient will receive a standardized anesthesia and analgesia procedure with a intravenous morphine patient controlled analgesia (PCA). Postoperative pain will be monitored at 1st, 3rd, 6th, 12th and 24th postoperative hours and morphine consumption rates will be recorded. Patient length of stay, time to first flatus, urine output, postoperative complications(graded by Clavien Dindo classification), preoperative and postoperative hemoglobin and creatinine levels will be filed.
- Conditions
- Post Operative Pain, Hemodynamic Instability, Hypercapnia, Complication,Postoperative, Intraoperative Complications
- Being tested
- Valveless Insufflator with 12 mmHg intra-abdominal pressure, Valveless Insufflator with 8 mmHg intra-abdominal pressure
- Keywords
- robotic surgery, intra-abdominal pressure, insufflator, postoperative pain, postoperative complications, intraoperative complications
- Medical subject headings
- Pain, Postoperative, Hypercapnia, Postoperative Complications, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valveless Insufflator with 12 mmHg intra-abdominal pressureDevice
In this group valveless insufflators, which are relatively new in clinical practice, will be used under low intra-abdominal pressure throughout the surgery.
Valveless Insufflator with 8 mmHg intra-abdominal pressureDevice
In this group valveless insufflators, which are relatively new in clinical practice, will be used under ultra-low intra-abdominal pressure throughout the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Valveless 12 | Experimental | Patients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 12 mmHg intra-abdominal pressure. Receives: Device: Valveless Insufflator with 12 mmHg intra-abdominal pressure |
| Valveless 8 | Experimental | Patients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 8 mmHg intra-abdominal pressure. Receives: Device: Valveless Insufflator with 8 mmHg intra-abdominal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of manipulations done by the attending anesthesiologists
After the induction of general anesthesia, orotracheal intubation and arterial catheterization; a standard ventilation and anesthesia maintenance strategy will be applied. Every manipulation performed to keep the parameters monitored by the anesthesiologists within physiological limits will be recorded: ventilation frequency setting, remifentail infusion titration, administration of vasoactive agents, etc.
Measured: Intraoperative
Secondary outcomes (24)
Arterial blood gas lactate levels
Arterial blood gas will be sampled at standardized times during the operation and lactate levels will be compared among the groups
Measured: Intraoperative
Peak airway pressures
Peak airway pressures (cmH2O) will be compared among the groups
Measured: Intraoperative
Mean airway pressures
Mean airway pressures (cmH2O) will be compared among the groups
Measured: Intraoperative
Lung compliance
Lung compliance (mL/cmH2O) will be compared among the groups
Measured: Intraoperative
End tidal carbon dioxide levels
End tidal carbon dioxide levels (mmHg) will be compared among the groups
Measured: Intraoperative
Minute ventilation
Minute ventilation (L/minute) will be compared among the groups
Measured: Intraoperative
Systolic blood pressure
Systolic arterial pressures (mmHg) will be compared among the groups.
Measured: Intraoperative
Diastolic blood pressure
Diastolic arterial pressures (mmHg) will be compared among the groups.
Measured: Intraoperative
Mean blood pressure
Mean arterial pressures (mmHg) will be compared among the groups.
Measured: Intraoperative
Heart rate
Heart rate (beat per minute) will be compared among the groups
Measured: Intraoperative
Acute Postoperative Pain
Acute postoperative pain reported with numeric rating scale (0-10) will be recorded at postoperative 1st, 3rd, 6th, 12th and 24th hours with 0 meaning no pain and 10 meaning worst imaginable pain.
Measured: Postoperative 24 hours
Postoperative morphine consumption
Intravenous morphine consumption (mg) will be recorded at postoperative 1st, 3rd, 6th, 12th and 24th hours
Measured: Postoperative 24 hours
Anesthesia time and operative time
Anesthesia and operative times wil be recorded as minutes
Measured: Intraoperative
Intraoperative bleeding
Total bleeding level estimated by the surgical nurse will be recorded as milliliters at the end of the surgery
Measured: Intraoperative
Urine output
Kidney function will be monitored by using intraoperative and daily postoperative urine output (mL)
Measured: Intraoperative and daily untill discharge
Creatinine levels
Kidney function will be monitored by using daily creatinine levels (mg/dL)
Measured: Preoperative and postoperative (up to one month)
Hemoglobin levels
Intraoperative and daily postoperative hemoglobin levels will be recorded
Measured: Intraoperative and daily untill discharge
Need for blood product transfusion
Blood product transfusions will be recorded
Measured: Intraoperative and daily untill discharge
Number of participants with pulmonary complications
Pulmonary complications like atelectasis, pulmonary oedema, pleural effusion, pneumothorax, pneumonia, ventilatory failure will be recorded for each patient. And number of patients with pulmonary complications will be compared among the groups.
Measured: Postoperative, up to one month
Flatus time
Postoperative time to first flatus will be recorded
Measured: Postoperative one week
Time to oral intake
Postoperative time to oral intake will be recorded
Measured: Postoperative 3 days
Number of participants with subcutaneous emphysema
Subcutaneous emphysema diagnosed with chest radiograph will be recorded
Measured: Postoperative, up to one month
Length of hospital stay
Length of hospital stay will be recorded as hours
Measured: Postoperative, up to one month
The Clavien-Dindo classification of surgical complications
Any postoperative complication will be graded by the Clavien-Dindo classification between I to V with I meaning any deviation from the postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions and V meaning death of a patient.
Measured: Postoperative, up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start15 Jul 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132490
- Sponsor's protocol ID
- 2022.094.IRB1.040
- Status last verified
- Sep 2023
- First submitted
- 20 Mar 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected for the study, including de-identified individual participant data will be made available to other within 6 months after the publication of this trial, as will additional related documents (study protocol, statistical analysis plan and informed consent form), for academic purposes (e.g , meta-analyses) upon request to the corresponding author, and with a signed data access agreement.
Publications
Feng TS, Heulitt G, Islam A, Porter JR. Comparison of valve-less and standard insufflation on pneumoperitoneum-related complications in robotic partial nephrectomy: a prospective randomized trial. J Robot Surg. 2021 Jun;15(3):381-388. doi: 10.1007/s11701-020-01117-z. Epub 2020 Jul 6.
PubMed 32632561Horstmann M, Horton K, Kurz M, Padevit C, John H. Prospective comparison between the AirSeal(R) System valve-less Trocar and a standard Versaport Plus V2 Trocar in robotic-assisted radical prostatectomy. J Endourol. 2013 May;27(5):579-82. doi: 10.1089/end.2012.0632. Epub 2013 Feb 5.
PubMed 23186377Paull JO, Parsacandola SA, Graham A, Hota S, Pudalov N, Obias V. The impact of the AirSeal(R) valve-less trocar system in robotic colorectal surgery: a single-surgeon retrospective review. J Robot Surg. 2021 Feb;15(1):87-92. doi: 10.1007/s11701-020-01071-w. Epub 2020 Apr 24.
PubMed 32333365La Falce S, Novara G, Gandaglia G, Umari P, De Naeyer G, D'Hondt F, Beresian J, Carette R, Penicka M, Mo Y, Vandenbroucke G, Mottrie A. Low Pressure Robot-assisted Radical Prostatectomy With the AirSeal System at OLV Hospital: Results From a Prospective Study. Clin Genitourin Cancer. 2017 Dec;15(6):e1029-e1037. doi: 10.1016/j.clgc.2017.05.027. Epub 2017 Jun 2.
PubMed 28669704
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Perioperative Effects of Intra-abdominal Pressure Created With Standard and Valveless Insufflators in Robotic Surgery
- ClinicalTrials.gov ID
- NCT06132490
- Acronym / sponsor ID
- 2022.094.IRB1.040
- Conditions
- Post Operative Pain, Hemodynamic Instability, Hypercapnia, Complication,Postoperative, Intraoperative Complications
- Keywords
- robotic surgery, intra-abdominal pressure, insufflator, postoperative pain, postoperative complications, intraoperative complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 15 Nov 2023 (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.
The main aim of this study is to compare the perioperative effects of different intra-abdominal pressures and different insufflators in patients undergoing robotic surgery at a 30-45 degree trendelenburg position.
Detailed description
Adult patients scheduled for robotic genitourinary or colorectal surgery are going to be enrolled in this study. Patients will be randomized in three groups. In group I, conventional insufflators will be used with 12 mmHg intra-abdominal pressure; in group II, valveless insufflators will be used with 12 mmHg intra-abdominal pressure and in group III, valveless insufflators will be used with 8 mmHg intra-abdominal pressure. Intraoperative data regarding airway pressures, lung compliance, hemodynamic parameters, arterial blood gas analysis, times of pressure loss and camera cleaning will be gathered. Each patient will receive a standardized anesthesia and analgesia procedure with a intravenous morphine patient controlled analgesia (PCA). Postoperative pain will be monitored at 1st, 3rd, 6th, 12th and 24th postoperative hours and morphine consumption rates will be recorded. Patient length of stay, time to first flatus, urine output, postoperative complications(graded by Clavien Dindo classification), preoperative and postoperative hemoglobin and creatinine levels will be filed.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valveless 12 | Experimental | Device: Valveless Insufflator with 12 mmHg intra-abdominal pressurePatients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 12 mmHg intra-abdominal pressure. |
| Valveless 8 | Experimental | Device: Valveless Insufflator with 8 mmHg intra-abdominal pressurePatients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 8 mmHg intra-abdominal pressure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective robotic surgery with intraabdominal insufflation and trendelenburg position (prostatectomy, hemicolectomy etc.)
- ASA (American Society of Anesthesiologists) Physical Status I-II-III
Key exclusion criteria (8 listed)
- Patients without consent
- Emergency surgery
- Bleeding diathesis
- Pregnancy or lactation
- Prior history of major abdominal/pelvic surgery
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 |
|---|---|---|
| Valveless Insufflator with 12 mmHg intra-abdominal pressureIn this group valveless insufflators, which are relatively new in clinical practice, will be used under low intra-abdominal pressure throughout the surgery. | Device | Valveless 12 |
| Valveless Insufflator with 8 mmHg intra-abdominal pressureIn this group valveless insufflators, which are relatively new in clinical practice, will be used under ultra-low intra-abdominal pressure throughout the surgery. | Device | Valveless 8 |
Primary outcome
Number of manipulations done by the attending anesthesiologists
Time frame: Intraoperative
After the induction of general anesthesia, orotracheal intubation and arterial catheterization; a standard ventilation and anesthesia maintenance strategy will be applied. Every manipulation performed to keep the parameters monitored by the anesthesiologists within physiological limits will be recorded: ventilation frequency setting, remifentail infusion titration, administration of vasoactive agents, etc.
24 secondary outcomes
Arterial blood gas lactate levels
Time frame: Intraoperative
Peak airway pressures
Time frame: Intraoperative
Mean airway pressures
Time frame: Intraoperative
Lung compliance
Time frame: Intraoperative
End tidal carbon dioxide levels
Time frame: Intraoperative
Minute ventilation
Time frame: Intraoperative
Systolic blood pressure
Time frame: Intraoperative
Diastolic blood pressure
Time frame: Intraoperative
Mean blood pressure
Time frame: Intraoperative
Heart rate
Time frame: Intraoperative
Acute Postoperative Pain
Time frame: Postoperative 24 hours
Postoperative morphine consumption
Time frame: Postoperative 24 hours
Anesthesia time and operative time
Time frame: Intraoperative
Intraoperative bleeding
Time frame: Intraoperative
Urine output
Time frame: Intraoperative and daily untill discharge
Creatinine levels
Time frame: Preoperative and postoperative (up to one month)
Hemoglobin levels
Time frame: Intraoperative and daily untill discharge
Need for blood product transfusion
Time frame: Intraoperative and daily untill discharge
Number of participants with pulmonary complications
Time frame: Postoperative, up to one month
Flatus time
Time frame: Postoperative one week
Time to oral intake
Time frame: Postoperative 3 days
Number of participants with subcutaneous emphysema
Time frame: Postoperative, up to one month
Length of hospital stay
Time frame: Postoperative, up to one month
The Clavien-Dindo classification of surgical complications
Time frame: Postoperative, up to one month
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 15 Mar 2024.
- Background: PubMed 32632561Feng TS, Heulitt G, Islam A, Porter JR. Comparison of valve-less and standard insufflation on pneumoperitoneum-related complications in robotic partial nephrectomy: a prospective randomized trial. J Robot Surg. 2021 Jun;15(3):381-388. doi: 10.1007/s11701-020-01117-z. Epub 2020 Jul 6.
- Background: PubMed 23186377Horstmann M, Horton K, Kurz M, Padevit C, John H. Prospective comparison between the AirSeal(R) System valve-less Trocar and a standard Versaport Plus V2 Trocar in robotic-assisted radical prostatectomy. J Endourol. 2013 May;27(5):579-82. doi: 10.1089/end.2012.0632. Epub 2013 Feb 5.
- Background: PubMed 32333365Paull JO, Parsacandola SA, Graham A, Hota S, Pudalov N, Obias V. The impact of the AirSeal(R) valve-less trocar system in robotic colorectal surgery: a single-surgeon retrospective review. J Robot Surg. 2021 Feb;15(1):87-92. doi: 10.1007/s11701-020-01071-w. Epub 2020 Apr 24.
- Background: PubMed 28669704La Falce S, Novara G, Gandaglia G, Umari P, De Naeyer G, D'Hondt F, Beresian J, Carette R, Penicka M, Mo Y, Vandenbroucke G, Mottrie A. Low Pressure Robot-assisted Radical Prostatectomy With the AirSeal System at OLV Hospital: Results From a Prospective Study. Clin Genitourin Cancer. 2017 Dec;15(6):e1029-e1037. doi: 10.1016/j.clgc.2017.05.027. Epub 2017 Jun 2.
- Individual participant dataSharing planned: Yes. Data collected for the study, including de-identified individual participant data will be made available to other within 6 months after the publication of this trial, as will additional related documents (study protocol, statistical analysis plan and informed consent form), for academic purposes (e.g , meta-analyses) upon request to the corresponding author, and with a signed data access agreement.
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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?
A study testing Valveless Insufflator with 12 mmHg intra-abdominal pressure and Valveless Insufflator with 8 mmHg intra-abdominal pressure in people with Post Operative Pain and Hemodynamic Instability, run by Koç 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 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 15 Mar 2024. 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?
Number of manipulations done by the attending anesthesiologists (time frame: Intraoperative). 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 NCT06132490, which also lists 4 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 15 Mar 2024.