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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Gerhard Pejcl Medizintechnik GmbH.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gerhard Pejcl Medizintechnik GmbH
ClinicalTrials.gov Identifier:
NCT00836680
First received: January 23, 2009
Last updated: February 2, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention
Internal Rectal Prolapse
Pelvic Floor Ptosis
Internal Hernia Into the Douglas Pouch
Device: Colorectal Stent

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

Resource links provided by NLM:


Further study details as provided by Gerhard Pejcl Medizintechnik GmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determination if the the use of the device will be tolerated by the patient combined with a low level of pain or discomfort. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: January 2009
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836680

Contacts
Contact: Michaela Abrahamowicz, Dr. med. 01143 6607668922 info@auau.at

Locations
Austria
St. Elisabeth Hospital Recruiting
Vienna, Austria, A-1220
Contact: Michaela Abrahamowicz, Dr. med.    01143 1 71126 ext 29    info@auau.at   
Principal Investigator: Michaela Abrahamowicz, Dr. med.         
Sponsors and Collaborators
Gerhard Pejcl Medizintechnik GmbH
Investigators
Principal Investigator: Michaela Abrahamowicz, Dr. med.
  More Information

No publications provided

Responsible Party: Gerhard Pejcl/Director, Gerhard Pejcl Medizintechnik GmbH
ClinicalTrials.gov Identifier: NCT00836680     History of Changes
Other Study ID Numbers: GPejcl-230109
Study First Received: January 23, 2009
Last Updated: February 2, 2009
Health Authority: Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:
Hernia
Prolapse
Rectal Prolapse
Hernia, Abdominal
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on September 18, 2014