Laparoscopic 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,…
ID
Bron
Aandoening
Laproscopic gastrostomy, gastric emptying, gastro-oesophageal reflux disease (GERD), children
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. To determine the effect of LGTP on gastric emptying in children, by comparing gastric emptying half time (T½) before and after operation;<br>
2. To identify predictors (gastric emptying) for success of a gastrostomy placement.
Achtergrond van het onderzoek
Laparoscopic 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 (T½) 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.
Doel van het onderzoek
Laparoscopic 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.
Onderzoeksopzet
Before 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.
Onderzoeksproduct en/of interventie
Laparoscopic gastrostomy placement.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Children (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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. History of gastric surgery;
2. Inability to undergo investigation.
Opzet
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In overige registers
Register | ID |
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NTR-new | NL3170 |
NTR-old | NTR3314 |
Ander register | METC UMC Utrecht : 11-029 |
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