Randomized, Prospective Controlled Trial of Paraesophagea... | NCT00272922

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

NCT00272922

Sponsor

Cook Group Incorporated

Status

Completed

Last Update Posted

Oct 18, 2007Estimated

Enrollment

150

Phase

Not Applicable

Conditions

Hernia
Paraesophageal Hernia

Interventions

hernia repair

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2002

Primary Completion Date

Not provided

Completion Date

Jul 2006Actual

First Submitted Date

Jan 4, 2006

First Submission Date that Met QC Criteria

Jan 4, 2006

First Posted Date

Jan 9, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2007

Last Update Posted Date

Oct 18, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Name	Type	Description	Arm Group Labels	Other Names
hernia repair	Device

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brant K Oelschlager, MD	University of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washington		Seattle	Washington	98195	United States

Condition Browse Module

MeSH Terms

ID	Term
D006547	Hernia
D006551	Hernia, Hiatal

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D006548	Hernia, Diaphragmatic
D000082122	Internal Hernia

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059685	Herniorrhaphy

Ancestor Terms

ID	Term
D019651	Plastic Surgery Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided