NCT00272922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

October 18, 2007

Status Verified

October 1, 2007

First QC Date

January 4, 2006

Last Update Submit

October 17, 2007

Conditions

HerniaParaesophageal Hernia

Keywords

BiomaterialsParaesophageal HerniaLaparoscopy

Interventions

hernia repairDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

HerniaHernia, Hiatal

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsHernia, DiaphragmaticInternal Hernia

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Study Officials

  • Brant K Oelschlager, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 4, 2006

First Posted

January 9, 2006

Study Start

July 1, 2002

Study Completion

July 1, 2006

Last Updated

October 18, 2007

Record last verified: 2007-10

Locations

US(1)