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NCT00272922 Clinical Trial

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

Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00272922
Other study ID # 02-1931-A-01 (Institution #)
Secondary ID
Status Completed
Phase N/A
First received January 4, 2006
Last updated October 17, 2007
Start date July 2002
Est. completion date July 2006

Study information
Verified date October 2007
Source Cook
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: University of Washington Human Subjects Review Committee
Study type Interventional

Clinical Trial 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 suture repair.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date July 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• hernia repair

Locations
Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Cook

Country where clinical trial is conducted

United States, 

See also
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Completed NCT01141335 - Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair Phase 4
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Completed NCT00032448 - Does Tension-Free Herniorrhaphy or Laparoscopic Herniorrhaphy Achieve Equal or Better Recurrence Rates and Lower Costs While Achieving Equivalent Outcomes for Hernia Patients? Phase 3
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Active, not recruiting NCT02439060 - PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit) N/A
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Completed NCT01997619 - Biological Mesh Repair of Complex Hernias in High Risk Patients N/A