Internal Hernia Clinical Trial
Official title:
Abdominal CT Angiography of Mesenteric Vessels for Diagnosing Internal Herniation After Roux-en-Y Gastric Bypass Surgery
Introduction: 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 clinically highly suspected after abdominal CT examination (but not necessarily
confirmed), the patient is subjected to diagnostic laparoscopic surgery. Unfortunately, a
negative abdominal CT scan does not exclude internal herniation in all patients. This pleads
for the development or exploitation of alternative 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.
Objectives: 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 population: Patients will be included who underwent laparoscopic RYGB surgery at least
half a year earlier and have persisting abdominal pain. They should be highly suspected for
internal herniation by their doctor, based on several characteristics.
Main study parameters/endpoints: 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 in 12 subjects.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: 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).
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01040364 -
Internal Hernias After Laparoscopic Gastric Bypass
|
N/A | |
| Recruiting |
NCT05710913 -
Development of Machine Learning Models for the Prediction of BMI and Complications After Bariatric Surgery (CABS-Study)
|