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

Gerhard Pejcl Medizintechnik

Status

Unknown

Conditions

Internal Hernia Into the Douglas Pouch

Pelvic Floor Ptosis

Internal Rectal Prolapse

Treatments

Device: Colorectal Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00836680

GPejcl-230109

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No 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