Internal Hernia Into the Douglas Pouch, Internal Rectal Prolapse, Pelvic Floor Ptosis
Conditions
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.
Interventions
DEVICEColorectal 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.
Sponsors
Gerhard Pejcl Medizintechnik GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Austria
Contacts
Primary ContactMichaela Abrahamowicz, Dr. med.
Outcome results
None listed