The effects of hiatal hernia repair and fundoplication on gastric emptying: a pilot study

• Conditions: middenrifbreuk; Delayed gastric emptying; 10017977; 10017998

• Registration Number: NL-OMON42596
• Lead Sponsor: Meander Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Objectively proven GERD (by gastroscopy and/or 24-hour pH and/or impedance monitoring)
- Age >=18

Exclusion Criteria

- BMI >= 30
- Pregnancy
- Achalasia
- Previous gastric surgery
- Previous esophageal surgery
- Inability to understand the Dutch language
- Inability to understand and/or fill in the questionnaires

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Gastric emptying scintigraphy (gastric retention at 0,1,2, and 4h, gastric<br /><br>emptying speed (T*) and lag phase duration)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Quality of Life<br /><br>- Patient satisfaction<br /><br>- Subjective DGE symptoms<br /><br>- Vagal nerve identification intra-operatively<br /><br>- Duration of surgery in minutes<br /><br>- Hiatal hernia size in cm<br /><br>- % peristaltic esophageal contractions<br /><br>- LES pressure in mmHg<br /><br>- Nadir LES relaxation pressure in mmHg</p><br>