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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Internal Rectal Prolapse
- Sponsor
- Gerhard Pejcl Medizintechnik GmbH
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- 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.
- Last Updated
- 17 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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 Outcomes
- 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)