Trial Outcomes & Findings for Observational Study of Anti-Reflux Surgery (NCT NCT01624506)
NCT ID: NCT01624506
Last Updated: 2021-06-08
Results Overview
Gastroesophageal Reflux Disease Health Related Quality of Life Outcomes (GERD-HRQL) Total scores range from 0-50 (min/max) 10 questions total, each rating 0-5 (min/max) Lower is better; higher is worse
Recruitment status
COMPLETED
Target enrollment
760 participants
Primary outcome timeframe
3 years post-surgery
Results posted on
2021-06-08
Participant Flow
Not required
Participant milestones
| Measure |
Magnetic Sphincter Augmentation
Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
|
Fundoplication
Patients treated with laparoscopic fundoplication
|
|---|---|---|
|
Overall Study
STARTED
|
530
|
230
|
|
Overall Study
COMPLETED
|
465
|
213
|
|
Overall Study
NOT COMPLETED
|
65
|
17
|
Reasons for withdrawal
| Measure |
Magnetic Sphincter Augmentation
Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
|
Fundoplication
Patients treated with laparoscopic fundoplication
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
29
|
15
|
|
Overall Study
Withdrawal by Subject
|
9
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
LINX explants
|
23
|
0
|
|
Overall Study
Adverse Event
|
3
|
0
|
Baseline Characteristics
Data not available for remaining subjects
Baseline characteristics by cohort
| Measure |
Magnetic Sphincter Augmentation
n=530 Participants
Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
|
Fundoplication
n=230 Participants
Patients treated with laparoscopic fundoplication
|
Total
n=760 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 13.7 • n=517 Participants • Data not available for remaining subjects
|
55.8 years
STANDARD_DEVIATION 12.1 • n=210 Participants • Data not available for remaining subjects
|
49.4 years
STANDARD_DEVIATION 13.9 • n=727 Participants • Data not available for remaining subjects
|
|
Sex: Female, Male
Female
|
198 Participants
n=519 Participants • Data not available for remaining subjects
|
113 Participants
n=215 Participants • Data not available for remaining subjects
|
311 Participants
n=734 Participants • Data not available for remaining subjects
|
|
Sex: Female, Male
Male
|
321 Participants
n=519 Participants • Data not available for remaining subjects
|
102 Participants
n=215 Participants • Data not available for remaining subjects
|
423 Participants
n=734 Participants • Data not available for remaining subjects
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Austria
|
27 participants
n=530 Participants
|
34 participants
n=230 Participants
|
61 participants
n=760 Participants
|
|
Region of Enrollment
Italy
|
104 participants
n=530 Participants
|
37 participants
n=230 Participants
|
141 participants
n=760 Participants
|
|
Region of Enrollment
United Kingdom
|
101 participants
n=530 Participants
|
26 participants
n=230 Participants
|
127 participants
n=760 Participants
|
|
Region of Enrollment
Germany
|
298 participants
n=530 Participants
|
133 participants
n=230 Participants
|
431 participants
n=760 Participants
|
|
Years with Gastroesophageal Reflux Disease (GERD)
|
9.0 years
STANDARD_DEVIATION 7.9 • n=518 Participants • Data not available for remaining subjects
|
8.9 years
STANDARD_DEVIATION 8.1 • n=207 Participants • Data not available for remaining subjects
|
9.0 years
STANDARD_DEVIATION 7.9 • n=725 Participants • Data not available for remaining subjects
|
|
Years with Proton Pump Inhibitors (PPI)
|
6.1 years
STANDARD_DEVIATION 5.4 • n=517 Participants • Data not collected for remaining subjects
|
5.8 years
STANDARD_DEVIATION 5.7 • n=203 Participants • Data not collected for remaining subjects
|
6.0 years
STANDARD_DEVIATION 5.5 • n=720 Participants • Data not collected for remaining subjects
|
PRIMARY outcome
Timeframe: 3 years post-surgeryPopulation: Enrolled subjects who completed the 3-year visit and responded to the Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL) questionnaire are included in the analysis.
Gastroesophageal Reflux Disease Health Related Quality of Life Outcomes (GERD-HRQL) Total scores range from 0-50 (min/max) 10 questions total, each rating 0-5 (min/max) Lower is better; higher is worse
Outcome measures
| Measure |
Magnetic Sphincter Augmentation
n=328 Participants
Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
|
Fundoplication
n=97 Participants
Patients treated with laparoscopic fundoplication
|
|---|---|---|
|
Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL)
|
4.2 score on a scale
Standard Deviation 5.7
|
4.9 score on a scale
Standard Deviation 7.8
|
Adverse Events
Magnetic Sphincter Augmentation
Serious events: 22 serious events
Other events: 98 other events
Deaths: 1 deaths
Fundoplication
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Magnetic Sphincter Augmentation
n=530 participants at risk
Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
|
Fundoplication
n=230 participants at risk
Patients treated with laparoscopic fundoplication
|
|---|---|---|
|
Injury, poisoning and procedural complications
Device erosion
|
0.19%
1/530 • Number of events 1 • 3 years
|
0.00%
0/230 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
10/530 • Number of events 11 • 3 years
|
0.00%
0/230 • 3 years
|
|
Gastrointestinal disorders
Gatric pain
|
0.38%
2/530 • Number of events 2 • 3 years
|
0.00%
0/230 • 3 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/530 • 3 years
|
0.43%
1/230 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Heartburn
|
0.57%
3/530 • Number of events 3 • 3 years
|
0.00%
0/230 • 3 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/530 • 3 years
|
0.43%
1/230 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/530 • 3 years
|
0.43%
1/230 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Worsening of GERD
|
1.1%
6/530 • Number of events 6 • 3 years
|
0.43%
1/230 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Magnetic Sphincter Augmentation
n=530 participants at risk
Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
|
Fundoplication
n=230 participants at risk
Patients treated with laparoscopic fundoplication
|
|---|---|---|
|
Gastrointestinal disorders
Heartburn
|
9.8%
52/530 • Number of events 61 • 3 years
|
6.1%
14/230 • Number of events 15 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
9.2%
49/530 • Number of events 54 • 3 years
|
7.0%
16/230 • Number of events 18 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER