The aim of this study is to verify our theory of an association between ACNES and pseudovisceral symptoms. We hypothesize in this study that fasting ghrelin blood level in ACNES patients with pseudovisceral symptoms and weight loss is lowered in…
ID
Source
Brief title
Condition
- Abdominal hernias and other abdominal wall conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in fasting ghrelin blood level
between ACNES patients and a healthy control group.
Secondary outcome
The difference in fasting ghrelin blood level before and after treatment for
ACNES.
The difference in fasting ghrelin blood level after treatment for ACNES between
the ACNES patients with a successful therapy and those with a failed therapy.
Background summary
The abdominal wall is an under recognized cause of abdominal pain, often due to
the anterior cutaneous nerve entrapment syndrome (ACNES) (1-3). This is caused
by unknown triggering of the anterior and lateral cutaneous branches of
anterior rami of thoracic intercostal nerves 7th-12th penetrating the rectus
abdominis muscle. These nerves innervate the abdominal wall sensory (4). Our
centre has noticed that about half of the ACNES patients exhibit a range of so
called pseudovisceral complaints such as bloating, relation of pain to food
ingestion, nausea, weight loss, etc. (5). We hypothesize that these symptoms
may reflect a disturbed segmental relation between a viscus and a dermatoma
resulting in a Head zone (6). Following this line of thought, the effect of
percutaneous electrical neurostimulation of these nerves was recently evaluated
in a RCT in obese patients. It was concluded that stimulation of Th 6 nerves
resulted in a significant loss of appetite and weight loss that was most
probably due to the creation of a somato-autonomic reflex (7). The same
research group described a direct correlation between appetite reduction and
ghrelin reduction after treatment with electrical neurostimulation at Th 6
nerve level in obese patients (10). Ghrelin is a peptide hormone produced by
mainly the gastric fundus that induces appetite. The aim of this study is to
demonstrate that there is an association between ACNES and pseudovisceral
complaints, We hypothesize that in patients with ACNES and visceral complaints
with a loss of appetite and weight loss, ghrelin levels are lowered. The
results of this study could learn us more of the etiology of ACNES.
Study objective
The aim of this study is to verify our theory of an association between ACNES
and pseudovisceral symptoms. We hypothesize in this study that fasting ghrelin
blood level in ACNES patients with pseudovisceral symptoms and weight loss is
lowered in comparison with a healthy control group.
Study design
Matched pilot study with 40 participants ( 20 intervention groep and 20 control
group)
Study burden and risks
Patients do not benefit of participation in this study but the outcome of this
study can contribute to the knowledge of ACNES. Patients receive investigation
and treatment as by standard of care for ACNES. There are no major risk
involving venepuncture for two times one blood sample. Timing will be in
consultation with the patient (day of surgery, whith consultation in the
morning, etc.).
Ds.Th.Fliednerstraat 1
Eindhoven 5631BM
NL
Ds.Th.Fliednerstraat 1
Eindhoven 5631BM
NL
Listed location countries
Age
Inclusion criteria
For the ACNES group
- diagnosed with ACNES
- at least two pseudovisceral complaints including loss of appetite related to
pain and weight loss defined as: unintentional and more than 5% of usual body
weight over at least 6 months
- age between 18 and 65
- receiving treatment for ACNES at our hospital
- obtained written informed consent
For the control group
- age between 18 and 65
- obtained written informed consent
Exclusion criteria
For the ACNES group
- BMI >= 30 kg/m2
- recent intra-abdominal pathology
- history of bariatric surgery
- endocrine disease
- psychiatric disorder
- can*t obtain adequate follow-up
- pregnancy
- language barrier
For the control group
- BMI >= 30 kg/m2
- ACNES
- weight loss over the last 6 months
- visceral complaints over the last month
- intra-abdominal pathology or surgery
- endocrine disease
- psychiatric disorder
- pregnancy
- language barrier
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 | NL72860.015.20 |
| Other | pending nederlands trial register |