CTA for Internal Herniation After RYGB Surgery

NCT ID: NCT03114761

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-05
• Study Completion Date: 2018-01-30

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).

Conditions

Internal Hernia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CTA-IH

Group Type: EXPERIMENTAL

CT angiography

Intervention Type: RADIATION

Patients are subjected to a standard abdominal CT scan and (additional in this study) to abdominal CT angiography (CTA)

Interventions

CT angiography

Patients are subjected to a standard abdominal CT scan and (additional in this study) to abdominal CT angiography (CTA)

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Laura Deden

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rijnstate hospital

Arnhem, , Netherlands

Countries

Netherlands

Other Identifiers

NL52257.091.15

Identifier Type: -

Identifier Source: org_study_id