Laparoscopic SurgeryPERFUSIONNCT03928171
The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery
A study testing Intra-abdominal pressure during laparoscopy in people with Laparoscopic Surgery and Pneumoperitoneum, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Peritoneal perfusion during laparoscopic surgery is quantified by video recording after intravenous injection of indocyanine green at a pneumoperitoneum pressure of 8, 12 and 16 mmHg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Surgery, Pneumoperitoneum
- What is being tested?
- Intra-abdominal pressure during laparoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jun 2018to 24 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥ 18 years old)
- Scheduled for robot-assisted colorectal laparoscopic surgery
Who cannot join
- Severe liver- or renal disease
- Pregnancy or lactation
- Planned diagnostics or treatment with radioactive iodine < 1 week after surgery
- BMI >35 kg/m2
- Known or suspected hypersensitivity to indocyanine green, sodium iodide or iodine
- Hyperthyroidism or thyroid adenomas
- Use of medication interfering with ICG absorption as listed in the summary of product characteristics.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, 6532SZ
About this study
Official title: The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery: a Pilot Study
Peritoneal perfusion during laparoscopic surgery is quantified by video recording after intravenous injection of indocyanine green at a pneumoperitoneum pressure of 8, 12 and 16 mmHg.
- Conditions
- Laparoscopic Surgery, Pneumoperitoneum
- Being tested
- Intra-abdominal pressure during laparoscopy
- Keywords
- Laparoscopic surgery, Pneumoperitoneum, Peritoneal perfusion, Intra-abdominal pressure
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-abdominal pressure during laparoscopyOther
Insufflation pressure of the abdomen during laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| Intra-abdominal pressure of 8 mmHg | Experimental | The laparoscopy insufflator is set to a pressure of 8 mmHg Receives: Other: Intra-abdominal pressure during laparoscopy |
| Intra-abdominal pressure of 12 mmHg | Experimental | The laparoscopy insufflator is set to a pressure of 12 mmHg Receives: Other: Intra-abdominal pressure during laparoscopy |
| Intra-abdominal pressure of 16 mmHg | Experimental | The laparoscopy insufflator is set to a pressure of 16 mmHg Receives: Other: Intra-abdominal pressure during laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal perfusion
Perfusion is quantified by video recording of the parietal peritoneum using the Firefly fluorescence module of the DaVinci surgical robot after intravenous injection of 0.2mg/kg indocyanine green. Fluorescent intensity in [-] over time is plotted in MATLAB, maximum fluorescent intensity and time to reach maximum fluorescent intensity are extracted.
Measured: 3 minutes after intravenous injection of indocyanine green
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start13 Jun 2018
- Primary completion24 Dec 2018
- Study completion24 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michiel C Warlé, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928171
- Sponsor's protocol ID
- 2018-4313
- Acronym
- PERFUSION
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2019
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Albers KI, Polat F, Loonen T, Graat LJ, Mulier JP, Snoeck MM, Panhuizen IF, Vermulst AA, Scheffer GJ, Warle MC. Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study. Int J Surg. 2020 May;77:8-13. doi: 10.1016/j.ijsu.2020.03.019. Epub 2020 Mar 17.
PubMed 32194255
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT03928171
- Acronym / sponsor ID
- PERFUSION / 2018-4313
- Conditions
- Laparoscopic Surgery, Pneumoperitoneum
- Keywords
- Laparoscopic surgery, Pneumoperitoneum, Peritoneal perfusion, Intra-abdominal pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 24 Dec 2018 (actual)
- Study completion
- 24 Dec 2018 (actual)
- First posted
- 26 Apr 2019 (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.
Peritoneal perfusion during laparoscopic surgery is quantified by video recording after intravenous injection of indocyanine green at a pneumoperitoneum pressure of 8, 12 and 16 mmHg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intra-abdominal pressure of 8 mmHg | Experimental | Other: Intra-abdominal pressure during laparoscopyThe laparoscopy insufflator is set to a pressure of 8 mmHg |
| Intra-abdominal pressure of 12 mmHg | Experimental | Other: Intra-abdominal pressure during laparoscopyThe laparoscopy insufflator is set to a pressure of 12 mmHg |
| Intra-abdominal pressure of 16 mmHg | Experimental | Other: Intra-abdominal pressure during laparoscopyThe laparoscopy insufflator is set to a pressure of 16 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (≥ 18 years old)
- Scheduled for robot-assisted colorectal laparoscopic surgery
Key exclusion criteria (7 listed)
- Severe liver- or renal disease
- Pregnancy or lactation
- Planned diagnostics or treatment with radioactive iodine < 1 week after surgery
- BMI >35 kg/m2
- Known or suspected hypersensitivity to indocyanine green, sodium iodide or iodine
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 |
|---|---|---|
| Intra-abdominal pressure during laparoscopyInsufflation pressure of the abdomen during laparoscopy | Other | Intra-abdominal pressure of 12 mmHg, Intra-abdominal pressure of 16 mmHg, Intra-abdominal pressure of 8 mmHg |
Primary outcome
Peritoneal perfusion
Time frame: 3 minutes after intravenous injection of indocyanine green
Perfusion is quantified by video recording of the parietal peritoneum using the Firefly fluorescence module of the DaVinci surgical robot after intravenous injection of 0.2mg/kg indocyanine green. Fluorescent intensity in [-] over time is plotted in MATLAB, maximum fluorescent intensity and time to reach maximum fluorescent intensity are extracted.
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 8 May 2020.
- Derived from this study: PubMed 32194255Albers KI, Polat F, Loonen T, Graat LJ, Mulier JP, Snoeck MM, Panhuizen IF, Vermulst AA, Scheffer GJ, Warle MC. Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study. Int J Surg. 2020 May;77:8-13. doi: 10.1016/j.ijsu.2020.03.019. Epub 2020 Mar 17.
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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.
Michiel C Warlé, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-abdominal pressure during laparoscopy in people with Laparoscopic Surgery and Pneumoperitoneum, run by Radboud University Medical Center at 1 site in Netherlands.
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 7 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 8 May 2020. 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 Netherlands. 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?
Peritoneal perfusion (time frame: 3 minutes after intravenous injection of indocyanine green). 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 NCT03928171, which also lists 1 linked publication.
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 8 May 2020.