gastroesophageal reflux, antireflux surgery, fundoplication, children
Conditions
Interventions
Laparoscopic Thal or Nissen fundoplication.
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Inability to undergo investigation; 2. Prior esophageal and/or gastric surgery, except gastrostoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of failed antireflux procedures: 1. Percentage time pH 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
| Measure | Time frame |
|---|---|
| Health-related quality of life. | — |
Contacts
Public ContactF.A. Mauritz
PO Box 85500
Outcome results
None listed