CTA for Internal Herniation After RYGB Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03114761
• Date of registration: 11/04/2017
• Prospective Registration: No
• Primary sponsor: Rijnstate Hospital
• Public title: CTA for Internal Herniation After RYGB Surgery CTA-IH
• Scientific title: Abdominal CT Angiography of Mesenteric Vessels for Diagnosing Internal Herniation After Roux-en-Y Gastric Bypass Surgery
• Date of first enrolment: September 5, 2016
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03114761
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Netherlands

Key inclusion & exclusion criteria

Inclusion Criteria:

- The patient should have underwent laparoscopic RYGB surgery (standard procedure with
closing of mesenteric openings) at least half a year earlier;

- The patient should have abdominal pain, at least three days in a row;

- The patient should be highly suspected for internal herniation by their doctor (based
on weight loss, location of pain, intervals between pain, relation to food intake).

Exclusion Criteria:

- The patient has an age below 18;

- The patient is incompetent to decide;

- The patient is pregnant or gives breast feeding;

- The patient is in emergency setting and requires imminent surgery;

- The patient has other known abdominal pathology or prior large abdominal surgery;

- The patient has had surgery for internal herniation previously;

- The patient has had earlier surgery involving the RYGB, such as distalisation;

- One or both scans have insufficient scan quality;

- The patient will not be subjected to diagnostic laparoscopic surgery (e.g. pain-free
patients);

- The patient has a contra-indication for the administration of oral or IV contrast
(Xenetide 300mg/ml).:

- Thyrotoxicose

- Overgevoeligheid/allergisch voor Xenetix of in het verleden een allergische
reactie op jodiumhoudend contrast

- Treatment with NSAID's, diuretica or aminoglycosiden that cannot be stopped 24
hours before and after the CT

- Treatment with cisplatina less than six weeks before CT

- M.Kahler or M. Waldenstrom

- Kidneyfunction (GFS) < 60



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Internal Hernia

Intervention(s)

Radiation: CT angiography

Primary Outcome(s)

CTA examination [Time Frame: 1 year]

Secondary Outcome(s)

Standard CT examination [Time Frame: 1 year]

Secondary ID(s)

NL52257.091.15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors