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

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

hernia repair

About this trial

This is an interventional treatment trial for Hernia focused on measuring Biomaterials, Paraesophageal Hernia, Laparoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00272922

First Posted

January 4, 2006

Last Updated

October 17, 2007

Sponsor

Cook Group Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT00272922

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

July 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cook Group Incorporated

4. Oversight

5. Study Description

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 suture repair.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hernia, Paraesophageal Hernia

Keywords

Biomaterials, Paraesophageal Hernia, Laparoscopy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

hernia repair

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brant K Oelschlager, MD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Hernia, Paraesophageal Hernia

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial