Status:
COMPLETED
Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)
Lead Sponsor:
Cook Group Incorporated
Conditions:
Hernia
Paraesophageal Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Documented symptomatic paraesophageal hernia
- Ability to participate in follow-up evaluation
- Has a telephone
- Free of cognitive or speech impairment
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00272922
Start Date
July 1 2002
End Date
July 1 2006
Last Update
October 18 2007
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195