Determinqtion of postoperative microdialysis values for pyruvate, lactate, glycerol and glucose after esophagectomy and gastric pull-upk, pancreaticoduodenectomy and sigmoid or rectum resection. Early detection of anastomotic laekage in patients…
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Brief title
Condition
- Other condition
Synonym
Health condition
maagdarmstelsel diagnostiek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determination of near anastomotic postoperative levels of pyruvate, lactate,
glycerol and glucose by micodialysis after esophagectomy and gastric pull-up.
Determination of postoperative levels of pyruvate, lactate, glycerol and
glucose by micodialysis of peritoneal fluid after sigmoid or rectum resection.
Determination of near anastomotic postoperative pyruvate, lactate, glycerol and
glucoselevels by micodialysis after pancreaticoduodenectomy.
Secondary outcome
Determination of postoperative levels of pyruvate, lactate, glycerol and
glucose in case of anastomotic leakage after sigmoid or rectum resection.
Correlation of microdialysis values to clinical and diagnostic findings.
Background summary
Failure of anastomotic healing is a major complication after esophagectomy,
pancreaticoduodenectomy and colorectal surgery. It has been shown to occur in
respectively 1,4 * 20%, 5-15% and 2-13% (Yeh et al., Harling et al.).. The
prognosis of these patients is uncertain and the outcome after such a
complication is dependent on early diagnosis and timely surgical or
radiological intervention. So far, identification of impaired anastomotic
healing exists of clinical examination, lab-results and CT-scanning. However,
in the early postoperative fase, these investigations lack sensitivity. Despite
the reported incidence of AL and its extensive consequences on morbidity,
mortality, hospital stay and costs, only a few studies have been undertaken to
evaluate diagnostic tools for early detection. It has been shown that a
decrease in local blood flow is a strong indicator for anastomotic leakage
after Upper and lowerGI surgery. Decreased blood flow causes local ischemia
which can be measured by microdialysis. Microdialysis is a relatively new tool
for continuous measurement of levels of pyruvate, lactate, glycerol and
glucose. The lactate / pyruvate ratio is a strong indicator for hypoxia,
whereas decreased glucoselevels indicate increase in metabolism. When local
ischemia progresses cells are broken down and glycerol is released. (Jansson et
al. Scand J Gastroenterol. 2004 May;39(5):434-9). By measurement of these
substances next to the anastomosis after upper- or lowerGI surgery anastomotic
leakage may be identified in a early preclinical stage.
Study objective
Determinqtion of postoperative microdialysis values for pyruvate, lactate,
glycerol and glucose after esophagectomy and gastric pull-upk,
pancreaticoduodenectomy and sigmoid or rectum resection.
Early detection of anastomotic laekage in patients after sigmoid or rectum
resection.
Study design
investigational cohort study
Study burden and risks
For patients in the DELFT-study, at the final stage of the esophagectomy a 0,9
mm microdialysiscatheter is placed subcutaneously next to the cervical
anastomosis. Next to this a referencecatheter is placed in the abdominal
subcutis located at least 10 cm from the laparotomy.
In the PALM-study, after the pancreaticoduodenectomy the microdialysis catheter
is placed next to the pancreaticoenterostomy. A second catheter is placed in
the subcutaneous fat in the abdominal wall 10 cm from the subcostal incision.
During the colorectal resection in the MICRo-study, the tip of the
microdialysis catheter is placed next to the anastomosis. A reference catheter
is placed in the adbominal wall.
Every 4 hours a sample is taken from both the anastomotic catheter as wel as
the subcutaneous catheter.
Every 12 hours a brief physical examination is carried out, as this is routine
in the daily care of postoperative patients, this does not convey additional
burden for the patient.
Virtually no catheter related complications were described in previous studies
(Reid et al. Ann Plast Surg. 2003 Dec;51(6):575-8). Patients should experience
no more discomfort from a microdialysis catheter than from routinely used
draining systems. Complications from devices like these include superficial
infection and pain. In case of both these complications, the microdialysis
catheter will be removed.
Reinier de Graafweg 3-11
2600 GA Delft
Nederland
Reinier de Graafweg 3-11
2600 GA Delft
Nederland
Listed location countries
Age
Inclusion criteria
Planned esophagectomy and gastric pull-up for preoperative T1-3N0-1M0 esophagus carcinoma, pancreaicoduodenectomy for resectable pancreatic or biliairy neoplasm, sigmoid or rectumresection for adenoma or carcinoma. Patients are capable of making decisions autonomously.
ASA class 1,2 and 3.
Exclusion criteria
ASA 4-5
<18 yr/old
Design
Recruitment
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL20712.098.08 |