The Biologic Basis of Hernia Formation

NCT01099033 | Completed

• 1 other identifier: 201104031
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

The study will examine potential biological and genetic mechanisms leading to hiatal and paraesophageal hernia formation in predisposed individuals. It is expected that these patients will have defects in the normal production and maturation of collagen and other connective tissue proteins, thus leading to weakness in the diaphragm that may allow for spontaneous herniation. Comparison of tissue and blood samples from these patients (study group) will be made to those from individuals undergoing lower esophageal surgery who have not developed a concurrent hernia (i.e. esophageal myotomy for achalasia and laparoscopic gastric bypass or laparoscopic adjustable gastric banding for morbid obesity - control group).

Conditions

Hiatal Hernia; Paraesophageal Hernia

Keywords

hiatal hernia; paraesophageal hernia; biologic mesh; MMPs; Hiatal/Paraesophageal hernia

Study Arms (2)

Hiatal/Paraesophageal hernia patients

patients with hiatal or paraesophageal hernias

control group

patients without hiatal or paraesophageal hernias who are undergoing crural dissection for heller myotomy, or who are undergoing gastric bypass surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients to be enrolled in the study will be standard referrals to our group from primary care physicians or other specialists who feel that surgical correction of a diaphragmatic hernia or achalasia is necessary. Additionally, patients referred to our practice for weight reduction surgery will also be considered eligible for enrollment.

You may qualify if:

• Any patient undergoing paraesophageal hernia repair, esophageal myotomy, laparoscopic gastric bypass, or laparoscopic adjustable gastric banding.

You may not qualify if:

• Pregnant females, minors, prisoners

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Musculoskeletal Transplant Foundation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Jansen PL, Mertens Pr Pr, Klinge U, Schumpelick V. The biology of hernia formation. Surgery. 2004 Jul;136(1):1-4. doi: 10.1016/j.surg.2004.01.004. No abstract available.

  PMID: 15232531 BACKGROUND

• Klinge U, Si ZY, Zheng H, Schumpelick V, Bhardwaj RS, Klosterhalfen B. Abnormal collagen I to III distribution in the skin of patients with incisional hernia. Eur Surg Res. 2000;32(1):43-8. doi: 10.1159/000008740.

  PMID: 10720845 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

small tissue biopsies of gastrohepatic, gastrophrenic, and phrenoesophageal ligaments

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Brent D Matthews, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Corey Deeken, PhD

  Washington University School of Medicine

  STUDY DIRECTOR

• Peggy Frisella, RN

  Washington University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2010
• First Posted: April 6, 2010
• Study Start: August 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

US (1)