No registrations found.
ID
Source
Health condition
gastroesophageal reflux, antireflux surgery, fundoplication, children
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of failed antireflux procedures:
1. Percentage time pH <4 (total time > 4%);
2. Number of reflux episodes/24hr (> 9);
3. Number of reflux episodes longer than 5 minutes (> 4);
4. Symptom scores (symptoms ≥ moderate-severe and/or daily-weekly);
Gastroesophageal function/motility:
1. Lower esophageal sphincter relaxation (% complete relaxation);
2. Percentage peristaltic contractions esophagus (%);
3. Contractions proximal/mid/distal esophagus (mmHg);
4. Gastric half-emptying time (min) as measured by 13C octanoic acid breath test;
5. Maximal proximal gastric adaptive relaxation (ml) as measured by 3D-US.
Success is defined as:
1. Complete symptom relief and normalised pH metry;
2. Complete symptom relief and near-normal pH metry;
3. Normalized pH metry and significant improvement of reflux symptoms (complaints less than mild/monthly).
Secondary outcome
Health-related quality of life.
Background summary
Rationale:
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 some 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 in adult GERD patients showed that proximal gastric distension may play an important role in triggering gastroesophageal reflux. Proximal gastric distension 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.
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 the innovative, non-invasive technique of 3D-ultrasound of the stomach offer additional value in the evaluation of the effect of antireflux surgery on gastroesophageal function?
5. What is the effect of antireflux surgery on health-related quality of life?
Study design:
A prospective, observational multicentre cohort study on children aged 0-18yrs being considered for antireflux surgery.
Study population:
Children (0-18yrs) with severe GERD,referred for antireflux surgery by a pediatrician/pediatric gastroenterologist and proven therapy-resistant or recurrent pathological gastroesophageal reflux.
Main study parameters/endpoints:
1. Percentage of failed antireflux procedures;
2. Gastroesophageal function/motility.
Study objective
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 some 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 in adult GERD patients showed that proximal gastric distension may play an important role in triggering gastroesophageal reflux. Proximal gastric distension 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 design
Before and 3-4 months after antireflux surgery the following tests will be performed:
1. Combined impedance monitoring/24pH monitoring/manometry;
2. 13C-Octanoic acid breath test;
3. Three-dimensional ultrasonography;
4. Reflux specific questionnaire: GSQ;
5. HRQoL questionnaire: PedsQL generic score scale 4.0.
Intervention
Laparoscopic Thal or Nissen fundoplication.
F.A. Mauritz
Department of Pediatric Surgery(KE.04.140.5)
Wilhelmina Children's Hospital
University Medical Hospital Utrecht
Utrecht 3508 GA
The Netherlands
+31 (0)88 7554004
f.a.mauritz@umcutrecht.nl
F.A. Mauritz
Department of Pediatric Surgery(KE.04.140.5)
Wilhelmina Children's Hospital
University Medical Hospital Utrecht
Utrecht 3508 GA
The Netherlands
+31 (0)88 7554004
f.a.mauritz@umcutrecht.nl
Inclusion criteria
Children (0-18yrs) with severe GERD:
1. Referred for antireflux surgery by a pediatrician/pediatric gastroenterologist and;
2. Proven therapy-resistant or recurrent pathological gastroesophageal reflux and;
3. In whom written informed consent can be obtained (Children >12yrs old and normally developed informed consent obtained from parents/guardians and child; Children <12 yrs and/or neurologically impaired informed consent obtained from parents/guardian).
Exclusion criteria
1. Inability to undergo investigation;
2. 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 |
|---|---|
| NTR-new | NL2794 |
| NTR-old | NTR2934 |
| Other | METC UMC Utrecht : 08/430 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |