Laparoscopic fundoplication for gastroesophageal reflux disease: A prospective study on reflux control and gastroesophageal motility

Laparoscopic fundoplication for gastroesophageal reflux disease: A prospective study on reflux control and gastroesophageal motility - Antireflux surgery in pediatric GERD patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38094

Enrollment

Registered

2009-06-09

Start date

2011-08-11

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

reflux disease vomiting

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Children (0-18 years) with gastroesophageal reflux disease (GERD) in whom 1. antireflux surgery is indicated by a pediatrician/pediatric gastroenterologist and 2. therapy-resistent or recurrent pathological gastroesophageal reflux is proven and 3. written informed consent can be obtained (In patients 12 yrs and mentally able, informed consent will be obtained from the parents/guardians and patients themselves)

Exclusion criteria

Exclusion criteria: - Inability to undergo investigation - prior esophageal and/or gastric surgery, except gastrostoma

Design outcomes

Primary

Measure	Time frame
1. Percentage of failed antireflux procedures - percentage time pH 4%) - amount of reflux episodes/24hr ( > 9 ) - amount of reflux episodes longer than 5 minutes ( > 4 ) - symptom scores (symptoms >= moderate-severe and/or daily-weekly) 2. gastroesophageal function/motility - lower esophageal sphincter relaxation (% complete relaxation) - percentage peristaltic contractions esophagus (%) - contractions proximal/mid/distal esophagus (mmHg) - gastric half-emptying time (min) - proximal gastric adaptive relaxation (ml) Success is defined as a. complete symptom relief and normalised pH metry b. complete symptom relief and near-normal pH metry c. normalized pH metry and significant improvement of reflux symptoms (complaints less than mild/monthly)	—

Measure

Time frame

1. Percentage of failed antireflux procedures - percentage time pH 4%) - amount of reflux episodes/24hr ( > 9 ) - amount of reflux episodes longer than 5 minutes ( > 4 ) - symptom scores (symptoms >= moderate-severe and/or daily-weekly) 2. gastroesophageal function/motility - lower esophageal sphincter relaxation (% complete relaxation) - percentage peristaltic contractions esophagus (%) - contractions proximal/mid/distal esophagus (mmHg) - gastric half-emptying time (min) - proximal gastric adaptive relaxation (ml) Success is defined as a. complete symptom relief and normalised pH metry b. complete symptom relief and near-normal pH metry c. normalized pH metry and significant improvement of reflux symptoms (complaints less than mild/monthly)

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Countries

Netherlands

Outcome results