NCT01776827

Completed

Long-term Outcome of Laparoscopic Hiatal Hernia Repair With ...

University of Nebraska Source

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Other study identifiers

Sponsor study identifier

0168-12-FB

Study Type

observational

Actual enrollment (reported)

69

Locations

1 country

Sites

1

Timeline

Study Start

May 22, 2012

Actual (reported)

Primary Completion

June 1, 2014

Actual (reported)

Study Completion

February 11, 2015

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 69 participants
Study completion date: February 11, 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 22, 2012
Actual (reported)
First Submitted
January 23, 2013
Actual (reported)
First Posted
January 28, 2013
Actual (reported)
Primary Completion
June 1, 2014
Actual (reported)
Study Completion
February 11, 2015
Actual (reported)

Last Updated: September 5, 2023
Status Verified: August 2023
Last Update Submitted: August 30, 2023

Conditions

Gastroesophageal Reflux Disease Hiatal Hernia Paraesophageal 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.

Sponsors & Collaborators

LifeCell
Industrycollaborator
University of Nebraska
Otherlead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

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

Enrollment

69 participants (actual enrollment reported by the registry).

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

Actual (reported)

Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair

Not ApplicableActive Not Recruiting

NCT01136980

Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study

Not ApplicableCompleted

NCT05974722

Mesh Vs Pledgets for Repair of Paraesophageal Hernia

Not ApplicableRecruiting

NCT01099033

The Biologic Basis of Hernia Formation

Completed

NCT01118585

Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)

Not ApplicableCompleted

NCT04695171

LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm

Terminated

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.

Primary Completion

June 1, 2014

Actual (reported)

Study Completion

February 11, 2015

Actual (reported)

Last Updated

September 5, 2023

Record last verified: 2023-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01776827
Data provider: ClinicalTrials.gov
Source updated: 2023-09-05
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:53 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations