Laparotomy
Conditions
Keywords
Laparotomy, Surgical Incisions, Wound Perfusion, 17-650
Brief summary
This study is being done to find out if Spectrum Near-Infrared (NIR) imaging with Indocyanine Green (ICG) dye can help measure blood flow around an incision before and after the surgeon closes the incision with staples or sutures. The Spectrum NIR imaging system uses a handheld camera that produces a special type of light that can help surgeons see things during surgery that are difficult to see with the naked eye, for example, cancer tissue versus healthy tissue. Spectrum NIR imaging has been approved by the Food and Drug Administration (FDA) as a tool that is widely used during surgery. ICG dye is a sterile solution that can be seen with Spectrum NIR imaging. This dye, used with Spectrum NIR imaging, allows surgeons to see blood flow to parts of the body during and after surgery. Making sure that there is enough blood flow to the surgical site helps to promote a less complicated recovery.
Interventions
PROCEDURELaparotomy
Laparotomy via vertical midline incision and after the planned surgical procedure is complete.
OTHERICG
ICG will be injected intravenously ICG is a fluorescent iodide dye.
OTHERSpectrum NIR imaging system
The Spectrum NIR imaging system uses a handheld camera that emits light in the NIR range.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Twenty consecutive patients will be enrolled: the first 10 will have skin closure with staples, and the second 10 will have skin closure with a running subcuticular suture.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Criteria for Eligibility Prior to Surgery Inclusion Criteria: * Woman undergoing a laparotomy procedure via a vertical midline incision for any indication with the Gynecology Service at MSK * Age ≥18 years
Exclusion criteria
* Women with hepatic dysfunction as evidenced by elevated transaminases * Women with a history of cirrhosis or other chronic liver disease * Women with an allergy to iodine * Women undergoing laparoscopic or minimally invasive surgery Criteria for Eligibility Post-Surgery Inclusion Criteria: * Woman undergoing a laparotomy procedure via a vertical midline incision for any indication with the Gynecology Service at MSK * Age ≥18 years Subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of cases with successful perfusion measurements | 1 year | Feasibility will be determined by the percentage of cases with successful perfusion measurements. |
Countries
United States
Outcome results
None listed