NCT04972357

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

10 months

First QC Date

July 12, 2021

Last Update Submit

July 12, 2021

Conditions

Gastric EmptyingRoux-en-Y Gastric BypassBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • Gastric emptying rate

    cross-sectional study. Measured once over a period of 45-60 minutes

Study Arms (3)

Standard RYGB

Banded RYGB

Extended pouch RYGB

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients who inderwent S-RYGB, B-RYGB or E-RYGB as a primary bariatric surgery.

You may qualify if:

  • Female patients who underwent S-RYGB, B-RYGB or E-RYGB as a primary bariatric surgery.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate Hospital

Arnhem, Netherlands

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2021

First Posted

July 22, 2021

Study Start

October 1, 2018

Primary Completion

July 16, 2019

Study Completion

July 16, 2019

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

NL(1)