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Study to Compare Peritoneal Ablation by Excision Only and Excision With the Use of an Adhesion Barrier

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ClinicalTrials.gov Identifier: NCT02165917
Recruitment Status : Unknown
Verified November 2015 by Prof. Dr. Dr. med. Rudy Leon De Wilde, Pius-Hospital Oldenburg.
Recruitment status was:  Recruiting
First Posted : June 18, 2014
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Dr. med. Rudy Leon De Wilde, Pius-Hospital Oldenburg

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endometriosis Procedure: Excision plus hyaluronic acid gel Procedure: Excision only Phase 4

Detailed Description:

Design: Prospective, monocentric, comparative, randomized, semi-blind.

There will be 30 subjects in each arm, who will be followed 15 months after surgery.

Half of the patients will receive standard laparoscopic excision of the endometriotic lesions only. The other half, after the excision of the endometriosis foci, will receive 10 cc of an antiadhesion agent which contents hyaluronic acid gel (Hyalobarrier®).The subjects will be hospitalized after surgery for at least 2 days.

A Vas-Scala will be given to the subjects to estimate the pain before, after surgery and one year after treatment. The participants will record the values each three months after surgery.

All subjects will be asked by telephone for the VAS-scala values and for pregnancy (Date of Initiation, clinical evolution)

The participation ist voluntary and an Informed consent must be signed before surgery. Subjects are free to withdraw their consent anytime.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Excision only
Laparoscopic excision of endometriotic lesions followed by 3 month of GnRH-Analogue administration
Procedure: Excision only
Excision of endometriosis foci by laparoscopic standard methods only.

Active Comparator: Excision plus hyaluronic acid gel
Standard Laparoscopic excision of endometriotic lesions plus application of 10 cc of a hyaluronic acid gel (Hyalobarrier® ), followed by 3 month of GnRH-analogue administration
Procedure: Excision plus hyaluronic acid gel
Excision of endometriosis foci by laparoscopic standard methods followed by an application of 10 cc Hyaluronic acid gel, in order to prevent postsurgical adhesions.




Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: One year after completion of endometriosis treatment (excision followed by 3 month of GnRH-analogues) ]

Secondary Outcome Measures :
  1. Endometriosis-associated pain [ Time Frame: The day before laparoscopy is performed ]
    Outcome measure is measured by visual analogue scale

  2. Endometriosis-associated pain [ Time Frame: One year after completion of endometriosis treatment ]
    Outcome measure is measured by visual analogue scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165917


Contacts
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Contact: Rudy L De Wilde, Professor +49 441 229 1501 gyn-sekretariat@pius-hospital.de

Locations
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Germany
Pius-Hospital, Department of Gynecology, Obstetrics and Gynecological Oncology, Carl von Ossietzky University Recruiting
Oldenburg, Lower Saxony, Germany, 26121
Contact: Rudy L De Wilde, Professor    +49 441 229 1501    gyn-sekretariat@pius-hospital.de   
Principal Investigator: Rudy L De Wilde, Professor         
Sponsors and Collaborators
Pius-Hospital Oldenburg
Investigators
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Principal Investigator: Rudy L De Wilde, Professor Pius-Hospital Oldenburg, Department of Gynecology, Obstetrics and Gynecological Oncology

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Responsible Party: Prof. Dr. Dr. med. Rudy Leon De Wilde, Professor Dr. Dr. med., Pius-Hospital Oldenburg
ClinicalTrials.gov Identifier: NCT02165917     History of Changes
Other Study ID Numbers: PHDW-003
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015

Keywords provided by Prof. Dr. Dr. med. Rudy Leon De Wilde, Pius-Hospital Oldenburg:
Endometriosis
Adhesions
Hyalobarrier®
Hyaluronic acid
Antiadhesion agent
Adhesionbarrier
Pregnancy rate

Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents