Completed

StratticeUse of Strattice in the Laparoscopic Suture Closure of a Paraesophageal Hernia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Internal Hernia+3

+ Hernia

+ Hernia, Diaphragmatic

Over 19 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2012
See protocol details

Summary

Principal SponsorUniversity of Nebraska
Last updated: September 6, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: March 5, 2012

Actual date on which the first participant was enrolled.

Prosthetic reinforcements reduce recurrence rates; the choice of optimal prosthetic, either synthetic or biosynthetic, for crural reinforcement is controversial. The objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large paraesophageal hernia repair. Strattice is a commonly used mesh in hernia repair. 35 adult (>19 years of age) patients will be selected based on inclusion and exclusion criteria. Patients who meet the criteria will be enrolled in the study. Information related to recurrence rates based on follow-up visits will be analyzed to determine the efficacy of Strattice in the prevention of large hernia recurrence.

NCT01678157
Principal SponsorUniversity of Nebraska
Last updated: September 6, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

35 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Internal HerniaHerniaHernia, DiaphragmaticPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalHernia, Hiatal

Criteria

7 inclusion criteria required to participate
Consenting adult 19 years of age or older
Documented symptomatic paraesophageal hernia
Evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum
Free of cognitive impairment
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7 exclusion criteria prevent from participating
Children and adolescents (19 years of age or younger)
Patients with associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of life assessment (e.g. Crohn's disease)
Patients with emergent operation for acute gastric volvulus
Patients with known sensitivity to porcine material
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Nebraska Medical Center

Omaha, United StatesOpen University of Nebraska Medical Center in Google Maps
CompletedOne Study Center