Use of Strattice Mesh in Paraesophageal Hernia Surgery

Hiatal Hernia Clinical Trial

— Strattice  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678157
• Other study ID #: 0314-11-FB
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Esophageal Hernia
• Hernia
• Hernia, Esophageal
• Hernia, Hiatal
• Hernia, Paraesophageal
• Hiatal Hernia
• Paraesophageal Hiatal Hernia
• Sliding Esophageal Hernia
• Sliding Hiatal Hernia

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