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 GmbH15 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Internal Rectal Prolapse Pelvic Floor Ptosis Internal Hernia Into the Douglas Pouch

Colorectal StentDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.