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Gastric Emptying in children with a gastrostomy.


- candidate number11250
- NTR NumberNTR3314
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-feb-2012
- Secondary IDs11-029 METC UMC Utrecht
- Public TitleGastric Emptying in children with a gastrostomy.
- Scientific TitleThe effect of a laparoscopic gastrostomy on gastric emptying and gastro-oesophageal reflux disease: A prospective observational study in children.
- ACRONYM
- hypothesisLaparoscopic gastrostomy tube placement (LGTP) is a frequently performed procedure to benefit pediatric patients with severe feeding difficulties. Most of these patients have significant neurologic impairment. In most children a LGTP is successful, because in time adequate caloric intake can be obtained through the gastric tube. Nevertheless, in 10% of patients a LGTP fails. Some believe that failure could be related to pre-existent delayed gastric emptying. However, this is not based on clinical evidence. An alternative route of enteral feeding is a laparoscopic jejunostomy tube placement (LJTP). A LJTP bypasses the stomach and is therefore hypothesised as a treatment of first choice in children with severe delayed gastric emptying, by some. However, a jejunostomy has major drawbacks. First, after a LJTP, all children are dependent on continues drip feeding, whereas with a LGTP it is possible to administer feedings in portions (bolus). Furthermore, complications as dislocation, obstruction, infection and adhesion ileus are more frequently seen after a LJTP. Gastric emptying studies have never been performed before and after LGTP in children. If a LGTP would lead to a significant increase in gastric emptying, there would be no reason to consider a gastrostomy contraindicated in patients with severe delayed gastric emptying. Subsequently, jejunostomy tubes need not be placed directly in patients with severe delayed gastric emptying.

Another issue concerning gastrostomy placements is that an increase of gastroesophageal reflux (GER) symptoms after gastrostomy placement is often described in scientific literature. GER is a passive flow of gastric (acidic) contents into the esophagus. However, only a few studies have used objective 24-hour monitoring to evaluate GER after gastrostomy placement. An increase in GER in these studies was not found, which could be explained by the fact that the studied patient population was too limited.Well-designed prospective studies using objective 24-hour pH monitoring in combination with reflux symptom severity scores are lacking.
- Healt Condition(s) or Problem(s) studiedGastric emptying, Gastroesophageal reflux Disease (GERD), Children, Laparoscopic gastrostomy
- Inclusion criteriaChildren (2-18yrs):
1. Referred for LGTP by a pediatrician/pediatric gastroenterologist;
2. Screened by the anaesthesiology department and have no contraindications for surgery;
3. In whom written informed consent can be obtained in:
A. Guardian/parents for all children <18 yrs;
B. Normally developed children >12 yrs.
- Exclusion criteria1. History of gastric surgery;
2. Inability to undergo investigation.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2012
- planned closingdate1-jul-2013
- Target number of participants50
- InterventionsLaparoscopic gastrostomy placement.
- Primary outcome1. To determine the effect of LGTP on gastric emptying in children, by comparing gastric emptying half time (T˝) before and after operation;
2. To identify predictors (gastric emptying) for success of a gastrostomy placement.
- Secondary outcome1. To determine the influence of a gastrostomy placement on gastroesophageal reflux;
2. To determine the effect of a gastrostomy on quality of life.
- TimepointsBefore and 3-4 months after laparoscopic gastrostomy placement the following tests will be performed:
1. 24pH-impedance monitoring;
2. 13C-Octanoic acid breath test;
3. Reflux specific questionnaire: GSQ;
4. 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)
Nuts/Ohra
- PublicationsN/A
- Brief summaryLaparoscopic gastrostomy tube placement (LGTP) is a frequently performed procedure to benefit pediatric patients with severe feeding difficulties. Most of these patients have significant neurologic impairment. In most children a LGTP is successful, because in time adequate caloric intake can be obtained through the gastric tube. Nevertheless, in 10% of patients a LGTP fails. Some believe that failure could be related to pre-existent delayed gastric emptying. However, this is not based on clinical evidence. An alternative route of enteral feeding is a laparoscopic jejunostomy tube placement (LJTP). A LJTP bypasses the stomach and is therefore hypothesised as a treatment of first choice in children with severe delayed gastric emptying, by some. However, a jejunostomy has major drawbacks. First, after a LJTP, all children are dependent on continues drip feeding, whereas with a LGTP it is possible to administer feedings in portions (bolus). Furthermore, complications as dislocation, obstruction, infection and adhesion ileus are more frequently seen after a LJTP. Gastric emptying studies have never been performed before and after LGTP in children. If a LGTP would lead to a significant increase in gastric emptying, there would be no reason to consider a gastrostomy contraindicated in patients with severe delayed gastric emptying. Subsequently, jejunostomy tubes need not be placed directly in patients with severe delayed gastric emptying.

Another issue concerning gastrostomy placements is that an increase of gastroesophageal reflux (GER) symptoms after gastrostomy placement is often described in scientific literature. GER is a passive flow of gastric (acidic) contents into the esophagus. However, only a few studies have used objective 24-hour monitoring to evaluate GER after gastrostomy placement. An increase in GER in these studies was not found, which could be explained by the fact that the studied patient population was too limited.Well-designed prospective studies using objective 24-hour pH monitoring in combination with reflux symptom severity scores are lacking.

Objective:
1. To determine the effect of LGTP on gastric emptying in children, by comparing gastric emptying half time (T˝) before and after operation;
2. To identify predictors (gastric emptying) for success of a gastrostomy placement;
3. To determine the influence of a gastrostomy placement on gastroesophageal reflux;
4. To determine the effect of a gastrostomy on quality of life.

Study design:
A prospective, observational cohort study in children aged 2-18yrs, undergoing LGTP.

Study population:
All children (2-18yrs), who are being considered for LGTP in the Wilhelmina Children’s Hospital, University Medical Center Utrecht.

Main study parameters/endpoints:
1. 13C octanoic acid breath test: Gastric halftime;
2. 24-hour pH-impedance monitoring: Total acid exposure time/ symptom association probability;
3. HRQoL questionnaire: total score.
- Main changes (audit trail)
- RECORD29-feb-2012 - 9-mrt-2012


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