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

Internal Hernia Into the Douglas Pouch Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00836680
• Other study ID #: GPejcl-230109
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2009
• Last updated: February 2, 2009
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: February 2009
• Source: Gerhard Pejcl Medizintechnik GmbH
• Contact: Michaela Abrahamowicz, Dr. med.
• Phone: 01143 6607668922
• Email: info[@]auau.at
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Abdominal
• Internal Hernia Into the Douglas Pouch
• Internal Rectal Prolapse
• Pelvic Floor Ptosis
• Prolapse
• Rectal Prolapse

Intervention

Device:
• Colorectal 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.

Locations

Country	Name	City	State
Austria	St. Elisabeth Hospital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Gerhard Pejcl Medizintechnik GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes