Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02612883 |
| Other study ID # |
VTG-04 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 18, 2015 |
| Est. completion date |
February 2021 |
Study information
| Verified date |
February 2021 |
| Source |
Technische Universität Dresden |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Tissue perfusion is a critical factor for tissue regeneration and healing of anastomoses.
Compromised microperfusion in the area where the anastomosis is sited likely contributes to
leaks, but until now there has not been an easy and reliable technique to intraoperatively
evaluate microperfusion.
Objectives: To assess the association of intraoperative flux measurement with postoperative
outcome of patients undergoing major abdominal surgery.
Trial design: Prospective observational study. Flux measurement will be carried out using the
moorVMS-LDF DUAL CHANNEL Laser Doppler Blood Flow system. The flux probe will be applied on
the respective organs (i.e. esophagus, stomach, liver, pancreas, colon, rectum) and
measurements will be documented after a stable signal has been obtained.
Description:
Surgical resection is the primary therapy for a variety of benign and malignant diseases of
the gastrointestinal tract. Advances in the perioperative care surgical technique and imaging
modalities have significantly improved the outcome of patients with major abdominal
resections within the past three decades. However, the incidence of postoperative
complications after major abdominal resections remains high with morbidity rates of 30-60%
despite a gradual decrease in perioperative mortality over time. Persistently high morbidity
rates may in part be explained by broadened indications with surgery in patients having
relevant comorbidities and/or advanced disease requiring extended resections. The reduction
of perioperative morbidity is of high relevance for the patients, as complications are
associated with poor oncological and functional long-term outcome and delay of further
therapy. In addition, complications present a major cause of costs for the health care
system.
Tissue perfusion is a critical factor for tissue regeneration and healing of anastomoses.
Compromised microperfusion in the area where the anastomosis is sited likely contributes to
leaks, but until now there has not been an easy and reliable technique to intraoperatively
evaluate microperfusion.
During the post-operative period, inadequate wound perfusion and impairment of systemic or
local oxygenation represent the main predisposing factors for anastomotic leakage. This is
the case for the gastric conduit as well as for colonic/rectal anstomoses.
For example, the performance of gastroplasty has been shown to be associated with impairment
in the microcirculatory blood flow in the proximal end of the gastric tube, despite the
absence of significant impairment in systemic haemodynamic status.
These microcirculatory impairments promote the occurrence of oesophageal anastomotic leakage,
which represents a potentially life-threatening complication related to the disastrous
consequences of the leakage of gastrointestinal contents, with mediastinitis, septic shock,
acute respiratory distress syndrome and death.
Similar results have been shown for colorectal anastomoses. So, a good microcirculatory blood
flow around the anastomosis could indicate an optimal condition for anastomotic healing. Or
the other way around, a bad microcirculatory blood flow could lead the surgeon to rethink the
planned anastomosis.
Objectives: To assess the association of intraoperative flux measurement with postoperative
outcome of patients undergoing major abdominal surgery.
Trial design: Prospective observational study. Flux measurement will be carried out using the
moorVMS-LDF DUAL CHANNEL Laser Doppler Blood Flow system. The flux probe will be applied on
the respective organs (i.e. esophagus, stomach, liver, pancreas, colon, rectum) and
measurements will be documented after a stable signal has been obtained.
Laser Doppler measurement allows realtime and continuous monitoring suitable for the
investigation of the gastrointestinal microcirculation. Light generated by a laser diode
penetrates the tissue, where it is reflected by circulating blood cells. This reflected light
is returned via an optical fibre to a photodetector and transformed into an electrical
signal, which is proportional to the number of blood cells moving in the measured volume
multiplied by the mean velocity of the cells, and is referred to as the blood flux expressed
as perfusion units (PU).
Each measurement represents the mean value (PU) of a stable perfusion over a 1-min period
without motion artefacts.
