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OpenTrials
Completed

NCT Number: NCT00272922

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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Key information

Conditions

Hernia Hernia, Diaphragmatic Hernia, Hiatal Internal Hernia Paraesophageal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hernia repair

Device

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Important dates

Study start
2002
Study completion
2006
First posted
Jan 9, 2006
Registry last updated
Oct 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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