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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04972357
Other study ID # 2018-1172
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date July 16, 2019

Study information

Verified date July 2021
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Gastric emptying measured with scintigraphy in patients after standard Roux-en-Y Gastric Bypass (S-RYGB), Banded-RYGB (B-RYGB) or Extended pouch-RYGB (E-RYGB).


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 16, 2019
Est. primary completion date July 16, 2019
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: Female patients who underwent S-RYGB, B-RYGB or E-RYGB as a primary bariatric surgery. Exclusion Criteria: (1) had a disease known to affect appetite, gastric emptying or gastrointestinal motility (e.g., diabetes mellitus or hyper-/hypothyroidism); (2) were unable to stop medications that affect gastric emptying and/or motility three days prior to measurements (e.g., anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids); (3) started menopause; (4) were pregnant or lactating; (5) had a drug or alcohol addiction; (6) were unable to stop smoking for 24 hours.

Study Design


Locations

Country Name City State
Netherlands Rijnstate Hospital Arnhem

Sponsors (1)

Lead Sponsor Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gastric emptying rate cross-sectional study. Measured once over a period of 45-60 minutes
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