The primary objective is to determine whether abdominal arterial CT angiography is a feasible technique for diagnosing internal herniation after RYGB surgery. Secondary, it is examined whether arterial angiography of the mesentery is superior over…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study endpoints are the assessments of the arterial abdominal angiogram
and mesenteric arterial mapping in relation to the outcome of the diagnostic
laparoscopic surgery.
Secondary outcome
Secondary study parameters are the assessments of the conventional CT abdomen,
the CT angiogram and the mesenteric arterial mapping, the comparison of these
images and the comparison of these images to the surgical outcome. The
sensitivity and specificity of both CT scans to diagnose an internal herniation
will be calculated
Background summary
Morbid obesity, defined as a body mass index (BMI) of over 40 kg/m2, is
globally an imminent health threat. Conservative therapies do often not yield
the desired result. Bariatric surgery includes several interventions that are
performed on patients with morbid obesity, like gastric bypass surgery. The
number of bariatric surgeries annually is estimated to be around 500,000
worldwide; about half of these are gastric bypass surgeries. In the
Netherlands, the most common performed bariatric intervention is the Roux-en-Y
gastric bypass (RYGB). An important long-term complication of this surgery is
internal herniation, a condition in which a part of the GI tract is herniated
through an opening in the mesentery made during RYGB surgery. Incidence of
internal herniation is 1-5%. Conventional abdominal CT examination is often not
conclusive about the presence of internal herniation. When internal herniation
is still highly suspected after abdominal CT examination (but not necessarily
confirmed), the patient is subjected to diagnostic laparoscopic surgery.
Contrary, a negative abdominal CT scan does not exclude internal herniation in
all patients. This pleads for the development or exploitation of new techniques
that might aid in the diagnosis of complications after RYGB surgery. Since the
anatomy of GI tract is altered when internal herniation is present, visualizing
the mesenteric vasculature may aid in the diagnosis of this complication after
RYGB surgery. This study aims to confirm the feasibility and superiority of
diagnosing internal herniation using CT examination of the mesenteric arteries
over conventional CT examination.
Study objective
The primary objective is to determine whether abdominal arterial CT angiography
is a feasible technique for diagnosing internal herniation after RYGB surgery.
Secondary, it is examined whether arterial angiography of the mesentery is
superior over conventional CT examination with oral and IV contrast in the
venous phase.
Study design
This study will be a prospective pilot study, in which the outcomes of both the
conventional CT examination and abdominal angiogram are compared to the outcome
of diagnostic laparoscopy as gold standard.
Study burden and risks
In this pilot study, study subjects will receive an additional effective
radiation dose of about 10 mSv. On average, an acute dose of 10 mSv leads to an
additional risk of cancer of about 1 in 1750 (~1 in 2000 for males, ~1 in 1500
for females) for a 50-year old subject, based on the linear no threshold model.
However, when the mesenteric artery mapping proves to be feasible and superior,
many unnecessary diagnostic laparoscopic surgeries will be prevented (along
with their complications and risks).
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
Patient have underwent laparoscopic RYGB surgery (the standard procedure with closing of mesenteric openings) at least half a year ago;
Patient has abdominal pain at least three days in a row
Patient is highly suspected for internal herniation judged by the surgeon and based on weight loss and pain (location of the pain, the intervals between pain, the relation to food intake).
Exclusion criteria
Age < 18 years;
Patient is incompetent to decide;
Patient is in emergency setting and requires imminent surgery;
Other abdominal pathology or prior large abdominal surgery;
Previous surgery for internal herniation;
Previous surgery involving the RYGB
One or both CT scans have insufficient scan quality;
The patient will not be subjected to diagnostic laparoscopic surgery.
Design
Recruitment
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 | NL52257.091.15 |