The aim of this monocenter observational pilot study is to determine the incidence and severity of gastric emptying disorders in patients with a hiatal hernia and to observe the effects of hiatal hernia repair and fundoplication on the gastric…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal motility and defaecation conditions
- Gastrointestinal therapeutic procedures
Synonym
Health condition
middenrifbreuk
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gastric emptying scintigraphy (gastric retention at 0,1,2, and 4h, gastric
emptying speed (T*) and lag phase duration)
Secondary outcome
- Quality of Life
- Patient satisfaction
- Subjective DGE symptoms
- Vagal nerve identification intra-operatively
- Duration of surgery in minutes
- Hiatal hernia size in cm
- % peristaltic esophageal contractions
- LES pressure in mmHg
- Nadir LES relaxation pressure in mmHg
Background summary
The normal physiology of the stomach is complicated and not yet fully
understood. Delayed gastric emptying (DGE) occurs in approximately 4% of the
worldwide population. The third (after diabetes and idiopathic) most common
cause is post surgical. The most common symptoms of delayed gastric emptying
are nausea, vomiting, postprandial fullness and pain, early satiety and
bloating. DGE is a very common complication that is accompanied by a very low
quality of life. There is no evidence about whether or not gastric emptying is
improved or worsened after HH repair and fundoplication. Also, there is no
agreement if fundoplication is a cause of or a solution for DGE.
Study objective
The aim of this monocenter observational pilot study is to determine the
incidence and severity of gastric emptying disorders in patients with a hiatal
hernia and to observe the effects of hiatal hernia repair and fundoplication on
the gastric emptying.
Study design
This is a prospective monocenter observational pilot study that investigates
the incidence and severity of gastric emptying disorders and the effects of
surgical management in patients with hiatal hernia in two cohorts: small (<3cm)
and large (>=3cm) hiatal hernia. This observational study will be conduced at
the Meander Medical Center in the Netherlands. Patients will be included during
a six-month period and will be followed for a minimum of 12 months.
Study burden and risks
This study is associated with a neglectable risk to the subjects* wellbeing.
All test subjects will undergo 2 gastric emptying studies (scintigraphy). The
annual acceptable dose for workers that may be exposed to radiation is 20mSv
per annum. Each scrintigraphy delivers a radiation dosage of 0,2mSv. A
radiation dosage that has no evident effect on the risk at getting cancer.
Maatweg 3
Amersfoort 3813 TZ
NL
Maatweg 3
Amersfoort 3813 TZ
NL
Listed location countries
Age
Inclusion criteria
- Objectively proven GERD (by gastroscopy and/or 24-hour pH and/or impedance monitoring)
- Age >=18
Exclusion criteria
- BMI >= 30
- Pregnancy
- Achalasia
- Previous gastric surgery
- Previous esophageal surgery
- Inability to understand the Dutch language
- Inability to understand and/or fill in the questionnaires
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 | NL54468.100.15 |