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

Completed · Not applicable

Conditions studied: Hernia, Paraesophageal Hernia

In brief

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.

Key facts

Study ID

NCT00272922

Run by

Cook Group Incorporated

People needed

150

Starts

2002-07-01

Expected to finish

2006-07-01

Last updated by the study team

2007-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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