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

NCT ID: NCT00836680

Last Updated: 2009-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-06-30

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.

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.

Conditions

Internal Rectal Prolapse; Pelvic Floor Ptosis; Internal Hernia Into the Douglas Pouch

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gerhard Pejcl Medizintechnik GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Gerhard Pejcl Medizintechnik GmbH

Principal Investigators

Michaela Abrahamowicz, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Locations

St. Elisabeth Hospital

Vienna, Vienna, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Michaela Abrahamowicz, Dr. med.

Role: CONTACT

info@auau.at

01143 6607668922

Facility Contacts

Michaela Abrahamowicz, Dr. med.

Role: primary

info@auau.at

01143 1 71126 ext. 29

Other Identifiers

GPejcl-230109

Identifier Type: -

Identifier Source: org_study_id