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CTA for Internal Herniation After RYGB Surgery (CTA-IH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114761
Recruitment Status : Unknown
Verified April 2017 by Frits Berends, Rijnstate Hospital.
Recruitment status was:  Recruiting
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Frits Berends, Rijnstate Hospital

Brief Summary:

Introduction: Morbid obesity, defined as a body mass index (BMI) of over 40 kg/m2, is globally an imminent health threat. Conservative therapies do often not yield the desired result. Bariatric surgery includes several interventions that are performed on patients with morbid obesity, like gastric bypass surgery. The number of bariatric surgeries annually is estimated to be around 500,000 worldwide; about half of these are gastric bypass surgeries. In the Netherlands, the most common performed bariatric intervention is the Roux-en-Y gastric bypass (RYGB). An important long-term complication of this surgery is internal herniation, a condition in which a part of the GI tract is herniated through an opening in the mesentery made during RYGB surgery. Incidence of internal herniation is 1-5%. Conventional abdominal CT examination is often not conclusive about the presence of internal herniation. When internal herniation is clinically highly suspected after abdominal CT examination (but not necessarily confirmed), the patient is subjected to diagnostic laparoscopic surgery. Unfortunately, a negative abdominal CT scan does not exclude internal herniation in all patients. This pleads for the development or exploitation of alternative techniques that might aid in the diagnosis of complications after RYGB surgery. Since the anatomy of GI tract is altered when internal herniation is present, visualizing the mesenteric vasculature may aid in the diagnosis of this complication after RYGB surgery. This study aims to confirm the feasibility and superiority of diagnosing internal herniation using CT examination of the mesenteric arteries over conventional CT examination.

Objectives: The primary objective is to determine whether abdominal arterial CT angiography is a feasible technique for diagnosing internal herniation after RYGB surgery. Secondary, it is examined whether arterial angiography of the mesentery is superior over conventional CT examination with oral and IV contrast in the venous phase.

Study design: This study will be a prospective pilot study, in which the outcomes of both the conventional CT examination and abdominal angiogram are compared to the outcome of diagnostic laparoscopy as gold standard.

Study population: Patients will be included who underwent laparoscopic RYGB surgery at least half a year earlier and have persisting abdominal pain. They should be highly suspected for internal herniation by their doctor, based on several characteristics.

Main study parameters/endpoints: Primary study endpoints are the assessments of the arterial abdominal angiogram and mesenteric arterial mapping in relation to the outcome of the diagnostic laparoscopic surgery in 12 subjects.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this pilot study, study subjects will receive an additional effective radiation dose of about 10 mSv. On average, an acute dose of 10 mSv leads to an additional risk of cancer of about 1 in 1750 (~1 in 2000 for males, ~1 in 1500 for females) for a 50-year old subject, based on the linear no threshold model. However, when the mesenteric artery mapping proves to be feasible and superior, many unnecessary diagnostic laparoscopic surgeries will be prevented (along with their complications and risks).


Condition or disease Intervention/treatment Phase
Internal Hernia Radiation: CT angiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Abdominal CT Angiography of Mesenteric Vessels for Diagnosing Internal Herniation After Roux-en-Y Gastric Bypass Surgery
Actual Study Start Date : September 5, 2016
Estimated Primary Completion Date : July 30, 2017
Estimated Study Completion Date : July 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: CTA-IH Radiation: CT angiography
Patients are subjected to a standard abdominal CT scan and (additional in this study) to abdominal CT angiography (CTA)




Primary Outcome Measures :
  1. CTA examination [ Time Frame: 1 year ]
    Assessment of the CT-angiography for the presence of internal herniation and comparing outcome to laparoscopic evalutation (gold standard)


Secondary Outcome Measures :
  1. Standard CT examination [ Time Frame: 1 year ]
    Standard radiologic examination of the standard CT, i.e. for the presence of internal herniation and comparison to the findings on CT-angiography and laparascopy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114761


Locations
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Netherlands
Rijnstate hospital Recruiting
Arnhem, Netherlands
Contact: Laura Deden, MSc    +31880058888    ldeden@rijnstate.nl   
Sponsors and Collaborators
Rijnstate Hospital

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Responsible Party: Frits Berends, MD, PhD, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT03114761    
Other Study ID Numbers: NL52257.091.15
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frits Berends, Rijnstate Hospital:
Roux-en-Y Gastric Bypass
Internal Herniation
Computed Tomography
Additional relevant MeSH terms:
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Hernia
Hernia, Abdominal
Pathological Conditions, Anatomical