Trial document





This trial has been registered retrospectively.
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  DRKS00009511

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 application 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 of reproductive age and represents a major cause of female infertility. Adhesions are often associated with the emergence of endometriosis, which also negatively affects the fertility of the affected woman.
In the study all patients with a suspicious of endometriosis and reproductive desire, will be laparoscopically operated , half of the participants will receive the standard care - ablation of the endometriosis foci- and the other half will receive additionally a gel for the reduction of post-surgical adhesions (Hyalobarrier®) .
Those patients with severe Endometriosis t - rASRM stage III / IV- , diagnosed at time of the laparoscopy, will receive a standard treatment with a GnRH analogue. In cases of slight and mild endometriosis (rASRM stage I / II) the surgical excision usually is enough to control the symptoms.
The primary endpoint is the pregnancy rate 12 months after laparoscopy, if only carried out the surgical removal of endometriosis; or if a subsequent GnRH analogues therapy is necessary , after completion of treatment with analogues. For this purpose, patients are interviewed by telephone one year later to asses the occurrence of pregnancy.
Study Design: Prospective, randomized controlled clinical trial. Single center, single-blind, that is, the participants do not know the nature of their treatment. There will be 30 participants recruited per treatment arm.
The results are expected to be published in an international medical journal.

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Brief Summary in Scientific Language

The prevalence of endometriosis in infertility patients is up to 50% A well recognized fertility-influencing factor is the subsequent formation of adhesions, which could lead to the destruction of the normal anatomy of the pelvic organs and dysfunction of the fallopian tubes, which are the cause of the negative impact on fertility.
For prophylaxis of postoperative adhesions various barrier methods can be applied. These have the aim to separate the affected area from other organs over the period of the healing.
Hyalobarrier® is a gel, which is approved for adhesion prevention and in Clinical Trials has proven its efficacy in the reduction of post-surgical adhesions after myomectomy.
Treatment with GnRH analogues is a Recognized therapy for endometriosis, which is given for the reduction of endometriosis-associated pain in cases of extensive or deep endometriosis (ASRM stage III and IV).
In this study is to be investigated, for the first time, the usefulness of the adhesion prophylaxis by means of Hyalobarrier® in order to improve the pregnancy rate and pain in patients with endometriosis.

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Organizational Data

  •   DRKS00009511
  •   2015/10/13
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  •   yes
  •   Approved
  •   15/11/13, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

  •   U1111-1175-4231 
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Health Condition or Problem studied

  •   N80.9 -  Endometriosis, unspecified
  •   N73.6 -  Female pelvic peritoneal adhesions
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Interventions/Observational Groups

  •   Patients will have ablation of the endometriosis foci by excision only.
  •   Patients will have ablation of the endometriosis foci by excision as well as the apliction of the adhesionsbarrier Hyallobarrier gel.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   IV
  •   No
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Primary Outcome

Assessment of the pregnancy rate 12 months after stopping treatment

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Secondary Outcome

Quantitative Parameters:- Duration of surgery; - Assessment of pain before and 12 Months after the Treatment

Descriptive Parameters: Applicability of the adhesions profilaxis gel (Hyalobarrier)on the 23 different posible localization of the endometriosis foci.

Visual analogue scale to assess pain:
Parameters: dysmenorrhea, pelvic pain independent of the menstrual period, lower back pain, Rectal pain / pain associated with defecation, dyspareunia

The subjects are asked about their average pain in the last three months.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/05/18
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   55   Years
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Additional Inclusion Criteria

Preoperative inclusion criteria:
- Women aged > 18 years with endometriosis-associated symptoms such as dysmenorrhea, dyspareunia, pelvic pain, back pain, Rectal, Defecation pain (the presence of individual complaints are accepted as an inclusion criterion)
- Subjects are in a good general state of health
- Up to endometriosis can be no other obvious diseases associated with chronic pain or other cause of abdominal pain
- The subjects have reproductive desire
- Subjects understand the course of the study and agree to participate
- The subjects must be the capacity to consent, that is, they must understand the risks and benefits of the study and are free to agreement to participate in the study
- There is a written consent form, by hand filled and signed, which has been confirmed by the competent ethics committee before.
Intraoperative inclusion criteria:
- Pelvic Endometriosis

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Exclusion Criteria

Preoperative exclusion criteria:
- Existing pregnancy, including an ectopic pregnancy
- In clinical examination there are findings of other causes of complaints
- Chronic diseases different of endometriosis which requires pain management
- Pre-treatment with GnRH analogues in a period of 6 months prior to study entry
- Use of systemic corticosteroids or antineoplastic drugs and / or performing an irradiation
- Planned additional general surgeries during the same surgery for endometriosis
Intraoperative exclusion criteria:
- no visible endometriosis foci at laparoscopy
- Evidence of an existing pregnancy, including a ectopic pregnancy
- Evidence of other causes of symptoms such as pelvic or abdominal infection, active or suspected malignancy, which are not associated with endometriosis
- The need for resection of intestinal segments to remove the endometriosis foci
- The need for resection of portions of the urinary bladder

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Addresses

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    • Pius-Hospital Universitätsklinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie
    • Mr.  Prof. Dr. Dr.  Rudy Leon  De Wilde 
    • Georgstraße 12
    • 26121  Oldenburg
    • Germany
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    • Pius-Hospital Universitätsklinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie
    • Mr.  Prof. Dr. Dr.  Rudy Leon  De Wilde 
    • Georgstraße 12
    • 26121  Oldenburg
    • Germany
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    • Pius-Hospital Oldenburg Abteilung Klinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie
    • Ms.  Dr. med  Angelika  Larbig 
    • Georgstraße 12
    • 26121  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • Pius-Hospital Klinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie
    • Mr.  Prof. Dr. Dr.  Rudy Leon  De Wilde 
    • Georgstraße 12
    • 26121  Oldenburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.