NCT01099033|Completed
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Sponsor study identifier
observational
151
1 country
1
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2011
Actual (reported)Study Completion
October 2011
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
April 2, 2010
Actual (reported)April 6, 2010
Actual (reported)October 2011
Actual (reported)October 2011
Actual (reported)patients with hiatal or paraesophageal hernias
patients without hiatal or paraesophageal hernias who are undergoing crural dissection for heller myotomy, or who are undergoing gastric bypass surgery
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.
Washington University School of Medicine
St Louis, Missouri, 63110, United States
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.
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.
small tissue biopsies of gastrohepatic, gastrophrenic, and phrenoesophageal ligaments
Brent D Matthews, MD
Washington University School of Medicine
Corey Deeken, PhD
Washington University School of Medicine
Peggy Frisella, RN
Washington University School of Medicine
151 participants (actual enrollment reported by the registry).
First Submitted
April 2, 2010
First Posted
April 6, 2010
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Hernia Sac Excision on Crural Tension in Paraesophageal Hernia Repair
Contact the study team to confirm eligibility.
Primary Completion
October 2011
Actual (reported)Study Completion
October 2011
Actual (reported)Last Updated
May 14, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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