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NCT03928171 Clinical Trial

The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery

Laparoscopic Surgery Clinical Trial

— PERFUSION  

Official title:
The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03928171
Other study ID # 2018-4313
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 13, 2018
Est. completion date December 24, 2018

Study information
Verified date April 2019
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 24, 2018
Est. primary completion date December 24, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Intra-abdominal pressure during laparoscopy
Insufflation pressure of the abdomen during laparoscopy

Locations
Country Name City State
Netherlands Canisius Wilhelmina Hospital Nijmegen Gelderland

Sponsors (1)
Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 3 minutes after intravenous injection of indocyanine green
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