Developing an evidence-based guideline for the diagnosis and surgical treatment of children with severe gastro-esophageal reflux disease.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Determining the pediatric patients with severe esophagogastric motility
disorders, prone to failure after laparoscopic antireflux surgery during the
preoperative work-up for GERD.
- Increase in succesrate of laparoscopic antireflux surgery in pediatric GERD
patients by improving selection criteria of these patients.
Secondary outcome
none
Background summary
Laparoscopic antireflux surgery (ARS) is one of the most common major
operations performed in pediatric patients. However, no prospective clinical
trials, in particular with use of investigative techniques, have been
published. Most studies are retrospective, case reports or evaluate ARS based
solely on symptoms. Data on the efficacy of laparoscopic ARS in children has
shown that although nearly 90% of patients had become asymptomatic, 25% still
had pathological reflux during pH monitoring. Factors determining the success
rate of laparoscopic ARS in pediatric GERD, are not completely understood.
However, based on a pilot study esophagogastric motility disorders seemed to be
associated with failure of ARS.
Study objective
Developing an evidence-based guideline for the diagnosis and surgical treatment
of children with severe gastro-esophageal reflux disease.
Study design
Observational research:
- prospective clinical trial, comparing data before and after laparoscopic
antireflux surgery
Study burden and risks
1. The impedance analysis/manometry are performed simultaneously with the
standard 24pH metry (therefore, no additional burden for the patient).
2. The 13C-breath test is not associated with any risks and the burden is
minimal since patients only have to consume a small meal (one pancake or glass
of milk) followed by non-invasive sampling of small amount of exhalation.
3. The 3D-ultrasound is not associated with any risks and the burden is minimal
since patients only have to consume a small amount of a liquid meal
(Nutridrink) followed by non-invasive measurement of the gastric volume and
emptying every 5 minutes during a 30-minute period (in between measurements
patients can watch television/walk around).
Lundlaan 6
3584 EA
Nederland
Lundlaan 6
3584 EA
Nederland
Listed location countries
Age
Inclusion criteria
Pediatric patients with severe GERD referred for antireflux surgery
Exclusion criteria
Inability to undergo investigation
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 | NL21620.041.08 |