Main questions:1. What is the success rate of antireflux surgery in children (reflux control) measured by means of validated and standardised investigation techniques?2. What is the effect of antireflux surgery on gastro-esophageal motility/function…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Percentage of failed antireflux procedures
- percentage time pH <4 (total time > 4%)
- amount of reflux episodes/24hr ( > 9 )
- amount of reflux episodes longer than 5 minutes ( > 4 )
- symptom scores (symptoms >= moderate-severe and/or daily-weekly)
2. gastroesophageal function/motility
- lower esophageal sphincter relaxation (% complete relaxation)
- percentage peristaltic contractions esophagus (%)
- contractions proximal/mid/distal esophagus (mmHg)
- gastric half-emptying time (min)
- proximal gastric adaptive relaxation (ml)
Success is defined as
a. complete symptom relief and normalised pH metry
b. complete symptom relief and near-normal pH metry
c. normalized pH metry and significant improvement of reflux symptoms
(complaints less than mild/monthly)
Secondary outcome
NA
Background summary
Antireflux surgery is one of the most common major operations performed in
pediatric patients. Most studies on the outcome of antireflux surgery in
children are limited to retrospective data, case reports or are based solely on
symptoms.
A prospective pilot study by van der Zee, pediatric surgeon Wilhelmina
Children's Hospital, University Medical Center Utrecht showed that asymptomatic
patients after antireflux surgery still had pathological reflux as measured by
pH metry.
To determine the outcome of antireflux surgery in children, it is essential to
objectively measure reflux before and after surgery. Van der Zee also showed
that 15% of failures after antireflux surgery were associated with severe
gastroduodenal dysmotility. Therefore, it is essential to objectively measure
the effects of antireflux surgery on gastroesophageal function and subsequently
evaluate if specific features of gastroesophageal function associated with
failed antireflux surgery can be identified during preoperative screening.
Studies on adult GERD patients showed that proximal gastric dilatation may play
an important role in triggering gastroesophageal reflux. Proximal gastric
dilatation was measured by invasive methods. Nowadays, it is possible to
measure this proximal gastric function in children by non-invasive
3D-ultrasound of the stomach.
Study objective
Main questions:
1. What is the success rate of antireflux surgery in children (reflux control)
measured by means of validated and standardised investigation techniques?
2. What is the effect of antireflux surgery on gastro-esophageal
motility/function?
3. Are there determinants associated with failed antireflux surgery that can be
identified during preoperative screening (risk stratification)?
Additional question:
4. Can innovative, non-invasive 3D-ultrasound of the stomach offer additional
value in the evaluation of the effect of antireflux surgery on gastroesophageal
function?
5. Study the effect of antireflux surgery on health-related quality of life
Study design
A prospective, observational cohort study on children aged 0-18yrs being
considered for antireflux surgery
Methods
- before operation and 3-4 months after operation the following questionnaires
will be performed:
* standardised reflux questionnaire
* Health-related Quality of Life questionnaire
- before operation and 3-4 months after operation the following investigation
techniques will be performed:
* manometry and 24-hr pH metry/impedance monitoring
* 13C-octanoic acid breath test (gastric emptying)
* 3D-ultrasound of the stomach
- all patients will undergo a laparoscopic fundoplication
Study burden and risks
The current manometry, pH metry and 13C breath test are standard investigation
techniques for the evaluation of reflux disease. Impedance monitoring and
3D-ultrasound of the stomach are additional investigation techniques. These
investigation techniques are not associated with any additional risk for the
patients.
The burden for patients is minimal because:
1. impedance: the current, smaller pH catheter is now equipped with impedance
monitoring. Therefore, there is no additional burden for the patient (only
additional data to be analysed by the researcher).
2. 3D ultrasound of the stomach: it is a short-lasting (30min) investigation
technique during which a fluid meal (300ml/m2 body surface area) is ingested
followed by non-invasive measurements of gastric volume and emptying every 5
minutes (in between measurements patients can watch tv/walk around/play). This
is the only non-invasive investigation technique that can measure proximal
gastric function in children.
Lundlaan 6
Utrecht 3584 EA
NL
Lundlaan 6
Utrecht 3584 EA
NL
Listed location countries
Age
Inclusion criteria
Children (0-18 years) with gastroesophageal reflux disease (GERD) in whom
1. antireflux surgery is indicated by a pediatrician/pediatric gastroenterologist and
2. therapy-resistent or recurrent pathological gastroesophageal reflux is proven and
3. written informed consent can be obtained (In patients <12 yrs and/or who are mentally disabled, informed consent will be obtained from the parents/legal guardian. In patients >12 yrs and mentally able, informed consent will be obtained from the parents/guardians and patients themselves)
Exclusion criteria
- Inability to undergo investigation
- prior esophageal and/or gastric surgery, except gastrostoma
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 | NL22977.041.08 |