A new device has been developed in the VU University Medical Center enabling us to measure perfusion pressure in mmHg in the bowel wall or wall of the gastric conduit. Correlating this measurement to systemic blood pressure in mmHg subsequently…
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Anastomotic perfusion expressed in a bowel-arm index.
Anastomotic perfusion expressed in a gastric conduit-arm index
Anastomotic dehiscence
Secondary outcome
none
Background summary
Anastomotic leakage remains a serious complication following colorectal surgery
and esophageal resection with gastric conduit. Its reported prevalence varies
between 1% and 39%. Currently, before making an anastomosis, viability of the
bowel or gastric conduit is estimated by the color of the tissue. This remains
very subjective and based on the experience of the surgeon. The aim of this
study is to investigate if measurements of perfusion at the site of anastomosis
expressed by a bowel-arm index or gastric conduit-arm index can help to predict
anastomotic dehiscence.
First a pilot study will be conducted.
Study objective
A new device has been developed in the VU University Medical Center enabling us
to measure perfusion pressure in mmHg in the bowel wall or wall of the gastric
conduit. Correlating this measurement to systemic blood pressure in mmHg
subsequently provides us a bowel-arm index or gastric conduit-arm index. In the
future, an anastomosis could subsequently be made where the bowel-arm index in
the bowel or gastric conduit-arm index is adequate and thus minimize the chance
of anastomotic leaks.
Study design
All patients undergoing colorectal, small intestinal surgery and esophageal
resection in the VU University Medical Center (VUmc), Academic Medical Center
(AMC), Zaans Medical Center (ZMC) and Medical Center Alkmaar (MCA), receiving a
primary anastomosis will be entered into this prospective study. Patients must
be 18 years and older. Informed consent must be obtained from all patients.
Patients undergoing palliative treatment or emergency surgery will be excluded
from this study. Standard anesthesia is given in all patients included in this
study.
Just before performing the anastomosis the bowel perfusion of the bowel wall is
measured in mmHg opposite of the mesenterium on both the oral and aboral side
of the anastomosis. This is believed to be the site of poorest perfusion in the
bowel wall. At the same time the systemic perfusion is measured using an
arterial catheter in the radial artery. Bowel perfusion in mmHg is divided by
the systemic pressure in mmHg providing us the bowel-arm index. Also the
surgeon is asked to subjectively evaluate the bowel perfusion.
In case of esophageal resection, after performing the gastric conduit, just
before the anastomosis is made, perfusion of the gastric conduit wall is
measured in mmHg opposite of the left gastric artery at the side of the
anastomosis. This is believed to be the site of poorest perfusion in the
gastric conduit. At the same time the systemic perfusion is measured using an
arterial catheter in the radial artery. Gastric conduit perfusion in mmHg is
divided by the systemic pressure in mmHg providing us the gastric conduit-arm
index. Also the surgeon is asked to subjectively evaluate the gastic conduit
perfusion.
Postoperatively patients are clinically followed for signs of anastomotic
leakage. Patients with an increase in abdominal pain, leukocyte level and/or
C-reactive protein level past postoperative day 3 will be evaluated for
anastomotic leakage by CT-scan with oral, rectal and IV contrast. In case of
esophageal resection this will be a CT scan of the chest with possibly a
gastroscopy. In addition, a CT-scan of the abdomen or thorax will be made at
any other postoperative day if deemed necessary by the treating physician.
We will investigate if a threshold in bowel-arm index or gastric conduit-arm
index will be able to help predict anastomotic leakage.
First a pilot study will be conducted.
Study burden and risks
No additional risk or burden is expected. The new device only exerts pressure
on the bowel wall and wall of the gastric conduit as would a surgical clamp for
instance. The perfusion measuring device has a CE approval. No addition out
patien clinic visits are planned.
Lange Leidsedwarsstraat 105
Amsterdam 1017 NJ
NL
Lange Leidsedwarsstraat 105
Amsterdam 1017 NJ
NL
Listed location countries
Age
Inclusion criteria
Elective bowel resection with primary anastomosis
Elective esophageal resection with gastric conduit reconstruction
Informed consent
Above 18 years of age
Exclusion criteria
No informed consent
Emergency surgery
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL36900.029.11 |