Trial Outcomes & Findings for Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial (NCT NCT01195545)

Results Overview

Number of subjects experiencing recurrence greater than 2cm as well as 5cm post surgery.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

6 months post procedure

Results posted on

2018-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	Veritas Mesh in Hernia Repair Subjects undergoing laparoscopic paraesophageal hiatal hernia repair using a bovine pericardium mesh (BP) (Veritas® collagen matrix, Synovis®, St. Paul MN) as a reinforcing material during the repair.
Overall Study STARTED	20
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Veritas Mesh in Hernia Repair Subjects undergoing laparoscopic paraesophageal hiatal hernia repair using a bovine pericardium mesh (BP) (Veritas® collagen matrix, Synovis®, St. Paul MN) as a reinforcing material during the repair.
Overall Study Protocol Violation	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Veritas Mesh in Hernia Repair n=20 Participants Subjects undergoing laparoscopic paraesophageal hiatal hernia repair using a bovine pericardium mesh (BP) (Veritas® collagen matrix, Synovis®, St. Paul MN) as a reinforcing material during the repair.
Age, Customized Age	66 years n=20 Participants
Sex: Female, Male Female	16 Participants n=20 Participants
Sex: Female, Male Male	4 Participants n=20 Participants
Region of Enrollment United States	20 participants n=20 Participants
BMI	28.7 kg/m^2 n=20 Participants

PRIMARY outcome

Timeframe: 6 months post procedure

Population: 6 months post-op follow up

Number of subjects experiencing recurrence greater than 2cm as well as 5cm post surgery.

Outcome measures

Outcome measures
Measure	Veritas Mesh in Hernia Repair n=16 Participants Subjects undergoing laparoscopic paraesophageal hiatal hernia repair using a bovine pericardium mesh (BP) (Veritas® collagen matrix, Synovis®, St. Paul MN) as a reinforcing material during the repair.
Recurrence Rate of Hiatal Hernia Rate Based on Upper Gastrointestinal (UGI) Series Recurrence >2cm	6 Participants
Recurrence Rate of Hiatal Hernia Rate Based on Upper Gastrointestinal (UGI) Series Recurrence >5cm	2 Participants
Recurrence Rate of Hiatal Hernia Rate Based on Upper Gastrointestinal (UGI) Series No evidence of recurrence.	8 Participants

SECONDARY outcome

Timeframe: Pre-surgery and 6 month follow up

Population: Pre-surgery and at a median follow up 6 months month (range 3 - 10 months)

Heartburn frequency Pre and Post-operative was measured using the Paraesophagel Hernia Patient Questionnaire-Visual analog score (VAS). The VAS measures subjective characteristics that specify the respondents level of agreement to a statement. In this questionnaire, the patient indicated how frequent they had Heartburn. The Heartburn frequency measurement scale: 0=Never, 1=once/month,2=once/week,3=once/day,4=several/day. The lower the VAS score the better the outcome meaning less episodes of Heartburn. The Heartburn VAS score was measured pre-operative and post-operative. The comparison of Heartburn VAS score pre-operative and post-operative indicated that participants experienced Improvement and No Improvement.

Outcome measures

Outcome measures
Measure	Veritas Mesh in Hernia Repair n=16 Participants Subjects undergoing laparoscopic paraesophageal hiatal hernia repair using a bovine pericardium mesh (BP) (Veritas® collagen matrix, Synovis®, St. Paul MN) as a reinforcing material during the repair.
Pre and Post-operative Symptoms With Improvement of Heartburn	15 Participants
Pre and Post-operative Symptoms No Improvement of Heartburn	1 Participants

SECONDARY outcome

Timeframe: Pre-surgery and 6 month follow up

Population: Pre-surgery an at median follow up of 6 month (3-6 month)

Regurgitation frequency Pre and Post-operative was measured using the Paraesophagel Hernia Patient Questionnaire-Visual analog score (VAS). The VAS measures subjective characteristics that specify the respondents level of agreement to a statement. In this questionnaire, the patient indicated how frequent they had Regurgitation. The Regurgitation frequency measurement scale: 0=Never, 1=once/month,2=once/week,3=once/day,4=several/day. The lower the VAS score the better the outcome meaning less episodes of Regurgitation. The Regurgitation VAS score was measured pre-operative and post-operative. The comparison of Regurgitation VAS score pre-operative and post-operative indicated that participants experienced Improvement and No Improvement.

Outcome measures

Outcome measures
Measure	Veritas Mesh in Hernia Repair n=16 Participants Subjects undergoing laparoscopic paraesophageal hiatal hernia repair using a bovine pericardium mesh (BP) (Veritas® collagen matrix, Synovis®, St. Paul MN) as a reinforcing material during the repair.
Pre and Post-operative Symptoms Improvement in regurgitation	11 Participants
Pre and Post-operative Symptoms No improvement in regurgitation	5 Participants

SECONDARY outcome

Timeframe: Pre-surgery and 6 month follow up

Population: Pre-surgery and a median of 6 month follow up (3-6months)

Dysphagia frequency Pre and Post-operative was measured using the Paraesophagel Hernia Patient Questionnaire-Visual analog score (VAS). The VAS measures subjective characteristics that specify the respondents level of agreement to a statement. In this questionnaire, the patient indicated how frequent they had Dysphagia. The Dysphagia frequency measurement scale: 0=Never, 1=once/month,2=once/week,3=once/day,4=several/day. The lower the VAS score the better the outcome meaning less episodes of Dysphagia. The Dysphagia VAS score was measured pre-operative and post-operative. The comparison of Dysphagia VAS score pre-operative and post-operative indicated that some participants experienced Improvement and others worsen.

Outcome measures

Outcome measures
Measure	Veritas Mesh in Hernia Repair n=16 Participants Subjects undergoing laparoscopic paraesophageal hiatal hernia repair using a bovine pericardium mesh (BP) (Veritas® collagen matrix, Synovis®, St. Paul MN) as a reinforcing material during the repair.
Pre and Post-operative Symptoms Dysphagia worsen	2 Participants
Pre and Post-operative Symptoms Dysphagia Improved	14 Participants

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brant Oelschlager, MD

University of Washington

Phone: 206-543-3518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place