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Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)

This study has been completed.
Sponsor:
Information provided by:
Cook
ClinicalTrials.gov Identifier:
NCT00272922
First received: January 4, 2006
Last updated: October 17, 2007
Last verified: October 2007

January 4, 2006
October 17, 2007
July 2002
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Complete list of historical versions of study NCT00272922 on ClinicalTrials.gov Archive Site
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Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)
Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)

The purpose of this randomized study is to determine whether a type of mesh derived from a layer of pig small intestine (SIS) is of benefit in treating paraesophageal hernias versus standard surgical suture repair.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hernia
  • Paraesophageal Hernia
Device: hernia repair
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
July 2006
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Inclusion Criteria:

  • Age > 18 years
  • Documented symptomatic paraesophageal hernia
  • Ability to participate in follow-up evaluation
  • Has a telephone
  • Free of cognitive or speech impairment

Exclusion Criteria:

  • Patients requiring intra-operative conversion to an open procedure
  • Unable to close the crura primarily
  • Short esophagus that requires the surgeon to perform a lengthening procedure
  • Previous operation of the esphagus or stomach
  • Associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of like assessment
  • Intraoperative full-thickness perforation of the esophagus
  • Emergent operation for acute volvulus
  • Ineffective peristalsis defined as average amplitude of peristalsis less than 30 mmHg or < 70% propagation of peristaltic waves in the distal esophagus
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00272922
02-1931-A-01 (Institution #)
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Cook
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Principal Investigator: Brant K Oelschlager, MD University of Washington
Cook
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP