Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007369

Trial Description

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Title

Randomised, Controlled Clinical Study With Patients With Endometriosis and the Desire to Have Children - Comparison Between Peritoneal Ablation by Excision Only and Excision With the Use of an Adhesionbarrier

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Endometriosis is a common disease of women in the reproductive age and is an important cause
for female infertility. Endometriosis is often associated with the development of adhesions
which further compromises the fertility of the affected women. The main purpose of this
study is to investigate the pregnancy rate one year after excision of endometriosis and
application of GnRH-analogues (Gonadotropin-releasing hormone) for 3 month. Half of the
patients will receive traditional endometriosis treatment with the excision of the
endometriotic lesions only. The other half will additionally receive a gel which can reduce
adhesion formation (Hyalobarrier®). Further study objective is the investigation in the
development of different types of endometriosis-associated pain over a period of one year.
Potential study participants are women with endometriosis-associated pain and with a desire
to have children. It will be investigated in the study if the use of Hyalobarrier® will
result in a higher pregnancy rate due to reduced adhesion development.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007369
  •   2016/03/22
  •   2014/04/15
  •   yes
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Secondary IDs

  •   NCT02165917  (ClinicalTrials.gov)
  •   PHDW-003  (Pius-Hospital Oldenburg)
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Health Condition or Problem studied

  •   Endometriosis
  •   N80 -  Endometriosis
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Interventions/Observational Groups

  •   Device: Excision plus Hyalobarrier
  •   Procedure: Excision only
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

- Pregnancy rate; time frame: One year after completion of endometriosis treatment (excision followed by 3 month of GnRH-analogues)

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Secondary Outcome

- Endometriosis-associated pain; time frame: The day before laparoscopy is performed; Outcome measure is measured by visual analogue scale
- Endometriosis-associated pain; time frame: One year after completion of endometriosis treatment; Outcome measure is measured by visual analogue scale

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/08/31
  •   60
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Inclusion Criteria

  •   Female
  •   18   Years
  •   45   Years
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Additional Inclusion Criteria

- Women over 18 years with endometriosis-associated pain, like dysmenorrhea,
dyspareunia, lower abdominal pain, low-back pain, rectal pain, defecation pain (only
one criterion needs to be fulfilled for study inclusion);

- Participants are in good general health except for endometriosis related problems;

- Except for endometriosis, no existence of an obvious diseases which could cause
chronic pain or which could cause abdominal pain;

- The participant must have a desire to have children;

- Participants must be able to give their consent and must understand the risks
associated with a participation in the study;

- There must be a signed and dated informed consent which was accepted by the local
ethic committee

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Exclusion Criteria

- Existent pregnancy including ectopic pregnancy;

- Identification of other causes for the discomfort;

- Chronic diseases, except endometriosis, which require continuous pain therapy;

- Previous application of GnRH analogues 6 month prior to study;

- Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation;

- Planned additional general surgical procedures during the operation for removal of
the endometriotic lesions;

- Absence of endometriosis at laparoscopy;

- Partial resection of the bowel or urinary bladder for removal of endometriosis

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Addresses

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    • Pius-Hospital Oldenburg
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    • Pius-Hospital Oldenburg, Department of Gynecology, Obstetrics and Gynecological Oncology
    • Rudy L De Wilde, Professor 
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    •   [---]*
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    • Rudy L De Wilde, Professor 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.