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出境医 / 临床实验 / The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery (PERFUSION)
The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery (PERFUSION)
Study Description
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Laparoscopic Surgery Pneumoperitoneum | Other: Intra-abdominal pressure during laparoscopy | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery: a Pilot Study |
| Actual Study Start Date : | June 13, 2018 |
| Actual Primary Completion Date : | December 24, 2018 |
| Actual Study Completion Date : | December 24, 2018 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Intra-abdominal pressure of 8 mmHg
The laparoscopy insufflator is set to a pressure of 8 mmHg
|
Other: Intra-abdominal pressure during laparoscopy
Insufflation pressure of the abdomen during laparoscopy
|
|
Experimental: Intra-abdominal pressure of 12 mmHg
The laparoscopy insufflator is set to a pressure of 12 mmHg
|
Other: Intra-abdominal pressure during laparoscopy
Insufflation pressure of the abdomen during laparoscopy
|
|
Experimental: Intra-abdominal pressure of 16 mmHg
The laparoscopy insufflator is set to a pressure of 16 mmHg
|
Other: Intra-abdominal pressure during laparoscopy
Insufflation pressure of the abdomen during laparoscopy
|
Outcome Measures
Primary Outcome Measures :
- 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adults (≥ 18 years old)
- Scheduled for robot-assisted colorectal laparoscopic surgery
Exclusion Criteria:
- 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.
Contacts and Locations
Locations
| Netherlands | |
| Canisius Wilhelmina Hospital | |
| Nijmegen, Gelderland, Netherlands, 6532SZ | |
Sponsors and Collaborators
Radboud University
Investigators
| Principal Investigator: | Michiel C Warlé, MD, PhD | Radboud University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 23, 2019 | ||||
| First Posted Date ICMJE | April 26, 2019 | ||||
| Last Update Posted Date | May 8, 2020 | ||||
| Actual Study Start Date ICMJE | June 13, 2018 | ||||
| Actual Primary Completion Date | December 24, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery | ||||
| Official Title ICMJE | The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery: a Pilot Study | ||||
| Brief 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Intra-abdominal pressure during laparoscopy
Insufflation pressure of the abdomen during laparoscopy
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| Study Arms ICMJE |
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| Publications * | Albers KI, Polat F, Loonen T, Graat LJ, Mulier JP, Snoeck MM, Panhuizen IF, Vermulst AA, Scheffer GJ, Warlé 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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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
30 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | December 24, 2018 | ||||
| Actual Primary Completion Date | December 24, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Netherlands | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03928171 | ||||
| Other Study ID Numbers ICMJE | 2018-4313 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Radboud University | ||||
| Study Sponsor ICMJE | Radboud University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Radboud University | ||||
| Verification Date | April 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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