Clinical Study for the Evaluation of the Efficiency of a Device for the Diagnosis of an Internal Rectal Prolapse, a Pelvic Floor Ptosis and for the Determination of an Internal Hernia Into the Douglas Pouch

Study Description

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Brief Summary:

The purpose of this study is to determine if the device is supplying sufficient diagnosis results of an internal rectal prolapse, of a pelvic floor ptosis and for the determination of an interal hernia into the Douglas pouch, as well as to determine the technical success of using the device at the patient.

Condition or disease	Intervention/treatment	Phase
Internal Rectal Prolapse; Pelvic Floor Ptosis; Internal Hernia Into the Douglas Pouch	Device: Colorectal Stent	Not Applicable

Detailed Description:

Existing diagnosis methods are inadequate, inaccurate, complicated or can only made intraoperatively. The new device should enable a fast and easy examination procedure well tolerated by the patients. The diagnosis results, received with the device, should assist in the accurate selection of patients for operations as well as to avoid any unnecessary operations.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	15 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Study for the Evaluation of the Efficiency of a Device for the Diagnosis of an Internal Rectal Prolapse, a Pelvic Floor Ptosis and for the Determination of an Internal Hernia Into the Douglas Pouch
Study Start Date :	January 2009
Estimated Primary Completion Date :	May 2009
Estimated Study Completion Date :	June 2009

Arms and Interventions

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Intervention Details:

Device: Colorectal Stent

Diagnosis of an internal rectal prolapse:

The device will be introduced and placed into the patient via a proctoscopic procedure. After that the doctor can measure and determine the internal rectal prolapse. After the diagnosis results have been received, the device will be removed from the patient via proctoscopic examination. The whole procedure will take approx. 5 minutes.

An additional X-ray examination procedure with the use of contrast media will be made for the determination of a pelvic floor ptosis and for the determination of an internal hernia into the Douglas pouch.

Outcome Measures

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Primary Outcome Measures :

1. Determination if the device will be effective for the diagnosis of an internal rectal prolapse, a pelvic floor ptosis and for the determination of an internal hernia into the Douglas pouch. [ Time Frame: 4 months ]

Secondary Outcome Measures :

1. Determination if the the use of the device will be tolerated by the patient combined with a low level of pain or discomfort. [ Time Frame: 4 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• female patients
• patients with ODS-Symptome-Score according Longo of >7
• existing results about a perceptible and seeable internal rectal prolapse, pelvic floor ptosis and an internal hernia into the Douglas pouch
• patients who correspond to to the ASA 1 - ASA 2 criteria

Exclusion Criteria:

• male patients
• female patients with inflammable or malign diseases of the urogenital tract as well as of the anorectal area and after rectum operation
• female patients with diarrhea
• pregnant patients because of the x-ray examination
• female patients who get anticoagulants
• serious cardiopulmonary disorders
• disorders of the blood coagulation
• female patients who correspond to the ASA 3 to ASA 4 criteria

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Michaela Abrahamowicz, Dr. med.	01143 6607668922	info@auau.at

Locations

Austria
St. Elisabeth Hospital	Recruiting
Vienna, Austria, A-1220
Contact: Michaela Abrahamowicz, Dr. med. 01143 1 71126 ext 29 info@auau.at
Principal Investigator: Michaela Abrahamowicz, Dr. med.

Sponsors and Collaborators

Gerhard Pejcl Medizintechnik GmbH

Investigators

Principal Investigator:	Michaela Abrahamowicz, Dr. med.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Gerhard Pejcl/Director, Gerhard Pejcl Medizintechnik GmbH
ClinicalTrials.gov Identifier:	NCT00836680 History of Changes
Other Study ID Numbers:	GPejcl-230109
First Posted:	February 4, 2009
Last Update Posted:	February 4, 2009
Last Verified:	February 2009

Additional relevant MeSH terms:

Hernia; Prolapse; Rectal Prolapse; Hernia, Abdominal; Pathological Conditions, Anatomical	Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pelvic Organ Prolapse