NCT01776827

Brief Summary

To study the long term outcome of Laparoscopic Hiatal Hernia Repair with human acellular dermal matrix Alloderm (LifeCell, Branchburg, NJ) mesh.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

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

May 22, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2015

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

January 23, 2013

Last Update Submit

August 30, 2023

Conditions

Gastroesophageal Reflux DiseaseHiatal HerniaParaesophageal Hernia

Keywords

GERDHiatal HerniaParaesophageal HerniaBiologic Mesh

Outcome Measures

Primary Outcomes (1)

  • Recurrence of hiatal hernia or GERD symptoms

    Patients will be questioned concerning their gastroesophageal reflux symptoms and hernia recurrence will be assessed using a barium swallow and x-rays.

    3+ years after initial surgery

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent paraesophageal hernia repair at the University of Nebraska Medical Center.

You may qualify if:

  • Subjects who underwent paraesophageal hernia repair at UNMC.
  • Greater than 19 years of age
  • Not pregnant

You may not qualify if:

  • Children and adolescents
  • Pregnant and breast-feeding patients
  • Vulnerable subjects such as decisionally impaired persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Gastroesophageal RefluxHernia, Hiatal

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Dmitry Oleynikov, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2013

First Posted

January 28, 2013

Study Start

May 22, 2012

Primary Completion

June 1, 2014

Study Completion

February 11, 2015

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations

US(1)