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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

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Colorectal Stent

About this trial

This is an interventional treatment trial for Internal Rectal Prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

St. Elisabeth HospitalRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Determination if the the use of the device will be tolerated by the patient combined with a low level of pain or discomfort.

Full Information

NCT ID

NCT00836680

First Posted

January 23, 2009

Last Updated

February 2, 2009

Sponsor

Gerhard Pejcl Medizintechnik GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00836680

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2009 (undefined)

Primary Completion Date

May 2009 (Anticipated)

Study Completion Date

June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Gerhard Pejcl Medizintechnik GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Colorectal Stent

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michaela Abrahamowicz, Dr. med.

Phone

01143 6607668922

info@auau.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michaela Abrahamowicz, Dr. med.

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Elisabeth Hospital

City

Vienna

ZIP/Postal Code

A-1220

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michaela Abrahamowicz, Dr. med.

Phone

01143 1 71126

Ext

info@auau.at

First Name & Middle Initial & Last Name & Degree

Michaela Abrahamowicz, Dr. med.

12. IPD Sharing Statement

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