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

Not Applicable

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

• Registration Number: NCT00836680
• Lead Sponsor: Gerhard Pejcl Medizintechnik GmbH

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-23
• Status Verified: 2009-02
• Study First Submitted QC: 2009-02-02
• Last Update Submitted: 2009-02-02
• Study First Posted: 2009-02-04
• Last Update Posted: 2009-02-04
• Primary Completion: 2009-05
• Study Completion: 2009-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	4 months

Secondary Outcome Measures

Name	Time	Method
Determination if the the use of the device will be tolerated by the patient combined with a low level of pain or discomfort.	4 months

Trial Locations

Locations (1)

St. Elisabeth Hospital; 🇦🇹 Vienna, Austria