Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06391255
Other study ID # 2023-2345
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 29, 2024
Est. completion date May 31, 2025

Study information

Verified date May 2024
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Oesophageal and gastric scintigraphy evaluates the function of the gastrointestinal system including variables such as oesophageal transit and gastric emptying (GE). Some variables are known to change after bariatric surgery. In patients that have symptoms of pain or nausea after bariatric surgery, oesophageal and gastric scintigraphy plays an important role in determining the nature of symptoms and is necessary for adequate treatment. However, literature on reference values in the bariatric population are scarce. At this moment, quantitative evaluation of the scintigraphy cannot be performed and conclusions are based on visual interpretation. There is a need for a standardised scintigraphy protocol for the population that underwent bariatric surgery taking into account the changed anatomy and physiology. Then, reference values that describe the oesophageal transit and GE assessed using scintigraphy have to be determined.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age between 18 and 65 years; - RYGB or SG as primary bariatric surgery; - A 2 year post-operative period without significant peri-operative or postoperative complications that could affect oesophageal transit, GE, or weight loss; - "Normal" weight loss, according to our expectations (25% < TWL < 35%); - Participants must be able to adhere to the study visit schedule and protocol requirements; - Participants must be able to give informed consent (IC) prior to any study procedures; - Willing to be informed about incidental findings of pathology and approving of reporting this to their general physician. Exclusion Criteria: - Pre-existent oesophageal or gastric motility disorders, dysphagia, reflux, dumping syndrome, (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; - Gluten intolerance; - Intolerance to tracer ingredients; - Participating in another scientific study at the same time, if this study interferes with the current study in any way.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
scintigraphy
oesophageal and gastric emptying

Locations

Country Name City State
Netherlands Rijnstate Hospital Arnhem Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary reference values for RYGB and GS patients gastric emptying (T1/2 [min], retention [%/min], caloric emptying [cal/min], GE curve over time) 2-3 years
Primary to describe SPECT/CT images and determine its benefit for anatomical correlation in asymptomatic (reference) and symptomatic population. 2-3 years
Primary to define reference values for RYGB- and SG-patients for oesophageal scintigraphy after bariatric surgery using an optimised protocol; transit time [min], emptying rate [%/min] 2-3 years
Secondary to explore the correlation of GE and oesophageal transit, and weight loss results or symptoms, using prospective data from this study and retrospective data from symptomatic patients and similar studies previously 2-3 years
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04517591 - Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study N/A
Active, not recruiting NCT04433338 - The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery N/A
Completed NCT05854875 - Diabetes Remission After RYGBP and RYGBP With Fundus Resection N/A
Recruiting NCT06460233 - Blood Pressure Changes After Bariatric Surgery
Completed NCT00535600 - Effects of Bariatric Surgery on Insulin
Withdrawn NCT04771247 - Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy N/A
Not yet recruiting NCT03203161 - Registry on Obesity Surgery in Adolescents
Enrolling by invitation NCT02552433 - Complications in Body Contouring Surgery
Completed NCT02525016 - Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery Phase 3
Recruiting NCT01984762 - Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus. N/A
Not yet recruiting NCT01652105 - Randomized Trial of Preoperative Diets Before Bariatric Surgery N/A
Completed NCT00989157 - Effects of Gastric Bypass on Blood Levels of Duloxetine Phase 3
Completed NCT03609632 - Understanding Hypoglycaemia After Bariatric Surgery N/A
Completed NCT05454696 - Online Clinic Pilates Exercises in Patients Undergoing Bariatric Surgery N/A
Completed NCT04040647 - Tolerance of Early Postoperative Mobilization and Ambulation
Recruiting NCT04297306 - Virtual Reality Exercise Gaming in Patients Awaiting Bariatric Surgery N/A
Recruiting NCT05428618 - Mobile Application for Bariatric Surgery Patients N/A
Not yet recruiting NCT03900481 - Use of an Endoluminal-suturing Device for Endoscopic Gastric Reduction as an Aid for Class I Obesity, or Class II Obesity Without Comorbidity N/A
Not yet recruiting NCT03975244 - Semi-supervised Exercise Program Before Bariatric Surgery N/A
Recruiting NCT06170749 - Prediction Model for Anemia After Bariatric Surgery