Reference values for gastric emptying scintigraphy after bariatric surgery

Recruiting

Conditions: obesitas, bariatrische chirurgie
being overweight
obesity

Registration Number: NL-OMON56655

Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

- age between 18 and 65 years;
- a 2 to 3 year postoperative period after bariatric surgery (gastric sleeve or
Roux-and-Y bypass as primary surgery);
- an umcomplicated procedure, and without symptoms of pain/nausea/etc;
- normal weight loss (defined as total weight loss [TWL]: 25% < TWL < 35%).

Exclusion Criteria

- Pre-existent oesophageal or gastric motility disorder, dysphagia, reflux,
(postprandial) abdominal pain, neurological or metabolic conditions that
significantly affect oesophageal or gastric motility;
- When using proton pump inhibitors (PPI) or H2-antagonists, the inability to
stop using them for 3 days;
- Using opioids;
- Previous oesophago-gastric surgery, other than bariatric surgery;
- Unable to stop smoking for 24h;
- Pregnancy or breast-feeding;
- Patients with a drug or alcohol addiction.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objectives:<br /><br>- to define reference values for gastric scintigraphy using an optimised<br /><br>protocol (GE in T1/2 and retention);<br /><br>- to define reference values for oesophageal scintigraphy using an optimised<br /><br>protocol;<br /><br>- to describe SPECT/CT images and determine its benefit for anatomical<br /><br>correlation in asymptomatic (reference) and symptomatic population.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives:<br /><br>- to explore the correlation of GE and oesophageal transit, and weight loss<br /><br>results or symptoms, using prospective data from this study and retrospective<br /><br>data from 53 symptomatic patients and similar studies previously (n=15,<br /><br>patients with RYGB) or currently (n = 24, patients with sleeve gastrectomy)<br /><br>performed in our centre, available for comparison. </p><br>