Trial Outcomes & Findings for Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH (NCT NCT03735862)

Results Overview

Patient self-report if they had a revision or other laparoscopic surgery following index procedure.

Recruitment status

COMPLETED

Target enrollment

85 participants

Primary outcome timeframe

6-18 months post index procedure

Results posted on

2019-10-01

Participant Flow

A consecutive cohort of patients who underwent a hiatal hernia repair between 1 Nov 2015 and 1 Mar 2017 at the principle investigator's private practice were identified. Patients were contacted by phone and asked if they were willing to participate. If so they were consented and enrolled.

12 patients declined participation or could not be contacted. These were included in the baseline analysis.

Participant milestones

Participant milestones
Measure	Observations Group Patients who have undergone a hiatal hernia repair with MIROMESH.
Overall Study STARTED	73
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Observations Group n=85 Participants Patients who have undergone a hiatal hernia repair with MIROMESH. Hepatic derived surgical matrix: Hiatal hernia repair with MIROMESH
Age, Categorical <=18 years	0 Participants n=85 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=85 Participants
Age, Categorical >=65 years	22 Participants n=85 Participants
Age, Continuous	55.9 Years STANDARD_DEVIATION 12.7 • n=85 Participants
Sex: Female, Male Female	55 Participants n=85 Participants
Sex: Female, Male Male	30 Participants n=85 Participants
Region of Enrollment United States	85 Participants n=85 Participants
GERD-HRQL	27.7 Score STANDARD_DEVIATION 9.3 • n=85 Participants
Proton Pump Inhibitor Use Yes	73 Participants n=85 Participants
Proton Pump Inhibitor Use No	12 Participants n=85 Participants

PRIMARY outcome

Timeframe: 6-18 months post index procedure

Population: 12 patients declined participation or could not be contacted.

Patient self-report if they had a revision or other laparoscopic surgery following index procedure.

Outcome measures

Outcome measures
Measure	Observations Group n=73 Participants Patients who have undergone a hiatal hernia repair with MIROMESH.
Number of Subjects Who Required a Revision of the Index Surgery.	0 Participants

SECONDARY outcome

Timeframe: 6-18 months post index procedure

Population: 12 patients declined participation or could not be contacted.

The GERD-HRQL score assess the severity of GERD symptomatic and impact on the subjects quality of life. The score is comprised of 10 questions whose answers are summed for the final score. THe score can range from 0 to 50, with 50 being the worst and 0 meaning no impact.

Outcome measures

Outcome measures
Measure	Observations Group n=73 Participants Patients who have undergone a hiatal hernia repair with MIROMESH.
Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL)	7.1 Score Standard Deviation 8.1

SECONDARY outcome

Timeframe: 6-18 months post index procedure

Population: 12 patients declined participation or could not be contacted. One patient did not answer.

Use of PPIs in 3-months prior to follow-up interview

Outcome measures

Outcome measures
Measure	Observations Group n=72 Participants Patients who have undergone a hiatal hernia repair with MIROMESH.
Medication Use Yes	7 Participants
Medication Use No	65 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-18 Months post index procedure

Population: 12 patients declined participation or could not be contacted.

Patients reported their satisfaction with the procedure as "Dissatisfied", "Neutral", or Satisfied.

Outcome measures

Outcome measures
Measure	Observations Group n=73 Participants Patients who have undergone a hiatal hernia repair with MIROMESH.
Satisfaction With Procedure Satisfied	63 Participants
Satisfaction With Procedure Neutral	6 Participants
Satisfaction With Procedure Dissatisfied	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-18 Months post index procedure

Population: 12 patients declined participation or could not be contacted.

Patients were asked to report how likely they would be to recommend this procedure to a friend or loved one with the same condition. Report was based on a scale of 1 (not at all likely) to 10 (very likely).

Outcome measures

Outcome measures
Measure	Observations Group n=73 Participants Patients who have undergone a hiatal hernia repair with MIROMESH.
Likelihood to Recommend <=3	3 Participants
Likelihood to Recommend >= 4 - <= 7	6 Participants
Likelihood to Recommend >=8	64 Participants

Adverse Events

Observations Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Observations Group n=73 participants at risk Patients who have undergone a hiatal hernia repair with MIROMESH.
Surgical and medical procedures Liver lobe tear	1.4% 1/73 • Number of events 1 • Operative & Peri-Operative, from admission for the surgical event through discharge. (Median length of stay 1 day)
Surgical and medical procedures Minor bleeding gastric vessels	1.4% 1/73 • Number of events 1 • Operative & Peri-Operative, from admission for the surgical event through discharge. (Median length of stay 1 day)
Surgical and medical procedures Arterial flutter	1.4% 1/73 • Number of events 1 • Operative & Peri-Operative, from admission for the surgical event through discharge. (Median length of stay 1 day)

Additional Information

Head of Clinical Affairs

Miromatrix

Phone: 952.942-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place