search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Antireflux surgery in pediatric GERD patients.


- candidate number9597
- NTR NumberNTR2934
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mei-2011
- Secondary IDs08/430 METC UMC Utrecht
- Public TitleAntireflux surgery in pediatric GERD patients.
- Scientific TitleLaparoscopic fundoplication for gastroesophageal reflux disease: A prospective study on reflux control and gastroesophageal motility.
- ACRONYM
- hypothesisAntireflux 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.
- Healt Condition(s) or Problem(s) studiedGastroesophageal reflux Disease (GERD), Children, Fundoplication
- Inclusion criteriaChildren (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 criteria1. Inability to undergo investigation;
2. Prior esophageal and/or gastric surgery, except gastrostoma.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2011
- planned closingdate31-dec-2013
- Target number of participants55
- InterventionsLaparoscopic Thal or Nissen fundoplication.
- Primary outcomePercentage 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 outcomeHealth-related quality of life.
- TimepointsBefore 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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. F.A. Mauritz
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M.Y.A. Herwaarden-Lindeboom, van
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Wilhelmina Children's Hospital research fund
- PublicationsN/A
- Brief summaryRationale:
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.
- Main changes (audit trail)
- RECORD31-mei-2011 - 21-jun-2011


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl