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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01678157
Other study ID # 0314-11-FB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 5, 2012
Est. completion date May 1, 2015

Study information

Verified date August 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date May 1, 2015
Est. primary completion date May 1, 2015
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Documented symptomatic paraesophageal hernia. - Greater than 5 cm hiatal hernia on upper gastrointestinal study. - Evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum. - Significant symptoms or signs of a paraesophageal hernia including but not limited to heartburn, dysphagia, chest pain, shortness of breath, postprandial abdominal pain, early satiety, odynophagia, or chronic anemia. - Consenting adult 19 years of age or older - Must be able to participate in follow-up evaluation. - Free of cognitive impairment Exclusion Criteria: - Children and adolescents (19 years of age or younger). - Pregnant and breast feeding patients. - Vulnerable subjects such as pregnant women, children less than 19 years age, and decisionally impaired persons. - Patients with previous operation of the esophagus or stomach. - 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.

Study Design


Locations

Country Name City State
United States University of Nebraska Medical Center Omaha Nebraska

Sponsors (2)

Lead Sponsor Collaborator
University of Nebraska LifeCell

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hernia recurrence A barium swallow test with x-rays will be performed to assess recurrence of hernia, if any 1 year post-surgery
Secondary Recurrence of reflux symptoms Patients will be evaluated for recurrence of reflux symptoms at the three postoperative visits. If recurrence warrants, a barium swallow with x-rays will be performed prior to 1-year primary outcome barium swallow test 2 weeks, 6 months and 1 year post-surgery
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