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
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ClinicalTrials.gov Identifier: NCT00836680
Verified February 2009 by Gerhard Pejcl Medizintechnik GmbH. Recruitment status was: Recruiting
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
Internal Rectal ProlapsePelvic Floor PtosisInternal Hernia Into the Douglas Pouch
Device: Colorectal Stent
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.
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.
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
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 ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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