Anastomotic Leak
Conditions
Keywords
Colorectal surgery, Near infrared, Indocyanine green, anastomotic leak, Prevention of leak
Brief summary
Anastomotic leak is a devastating complication of colorectal surgery. There is no widespread means of assessing the viability of a laparoscopic anastomosis. The investigators described recently the feasibility of microvascularisation assessment with near-infra red technology (NIR). The aim of this study is to look at the implementation of this technique in a wider prospective series of patients undergoing colorectal resection.
Detailed description
Multicentric prospective study of 260 consecutive patients undergoing colonic resection and being assessed during the course of surgery for microvascularisation. After vessel division and after colorectal anastomosis, indocyanine green (2.5mg/ml) is injected intravenously and anastomotic microvascularisation assessed with the PinPoint NIR system (Novadaq, Vancouver, Canada). Study primary endpoint is the anastomotic leak rate Secondary endpoint are peroperative and post-operative complications according to the Clavien Dindo scale, time of the procedure and time to record a signal as well as any change of the procedure. This study will be performed on 3 different sites Geneva, Oxford and Dublin University Hospitals
Interventions
PROCEDURENIR anastomotic perfusion assessment
Patient will have their anastomosis assessed by near infrared technology after indocyanine green has been injected i.v. The procedure will be repeated twice, once before the anastomosis and the second time after the anastomosis has been performed.
DEVICENear infrared camera
Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green
Sponsors
Oxford University Hospitals NHS Trust
University College Dublin
University Hospital, Geneva
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is willing and able to give informed consent for participation in the study. * Participant willing and able to comply with the study procedures. * Diagnosed with required colon or rectal neoplasia requiring surgical excision by either laparoscopic or open surgery. * A negative pregnancy test for women of childbearing potential prior to surgery * Able (in the Investigators opinion) and willing to comply with all study requirements
Exclusion criteria
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study. * Allergy to Indocyanine green. * Participant who is undergoing purely palliative surgery or who is terminally ill * Subject has other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic leak rate | first 30 days | anastomotic leak rate at 30 post operative days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to perform the near infrared procedure | during surgery | measured added time to the procedure |
| Time to get a near infrared signal | during surgery | Time to see a signal during surgery |
| complication rate | 30 days | according to Clavien Dindo classification |
| Mortality | 30 days | 30 days mortality |
| Alteration of the course of surgery due to insufficient vascularisation | during surgery | If the vascularisation is insufficient during the surgery, the investigators can change the course of the surgery he is performing. For example, it could lead to a second resection to obtain well vascularized tissue for the anastomosis. Any alteration of the regular course of surgery for the safety of the patient is reported. The number of patient requiring an alteration of the course of surgery will be recorded. |
Countries
Ireland, Italy, Switzerland, United Kingdom
Outcome results
None listed