Laparoscopic Antireflux Surgery Versus Endoscopic Full-th... | NCT01324791

Studies
Laparoscopic Antireflux Surgery Versus Endoscopic Full-thickness Gastroplication for Gastroesophageal Reflux Disease (GERD)

NCT01324791

Sponsor

General Public Hospital Zell am See

Status

Completed

Last Update Posted

Mar 29, 2011Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Gastroesophageal Reflux Disease

Interventions

anti-reflux surgery

Countries

Austria

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

Mar 2011

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 26, 2011

First Submission Date that Met QC Criteria

Mar 28, 2011

First Posted Date

Mar 29, 2011Estimated

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

Mar 28, 2011

Last Update Posted Date

Mar 29, 2011Estimated

Description Module

Brief Summary

Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a safe and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms of GERD. This prospective randomized study compares objective and subjective outcome parameters of Plicator with that of LARS.

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laparoscopic antireflux surgery	Active Comparator		Procedure: anti-reflux surgery
endoscopic full-thickness-gastroplication	Active Comparator		Procedure: anti-reflux surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
anti-reflux surgery	Procedure		endoscopic full-thickness-gastroplication laparoscopic antireflux surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

long history of GERD symptoms
persistent or recurrent symptoms despite optimal medical treatment
persistent or recurrent complications of GERD
reduced quality of life owing to increasing esophageal exposure to gastric juice
pathological values in the preoperative evaluated functional parameters.

Exclusion Criteria:

any distinct hiatal hernia detectable by gastroscopy or barium radiography
dysphagia
esophageal strictures
poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.

Accepts Healthy Volunteers

Not provided

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

Facility	Status	City	State	ZIP	Country	Contacts
GPH Zell am See		Zell am See	State of Salzburg	5700	Austria

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided