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
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis||Procedure: Excision plus hyaluronic acid gel Procedure: Excision only||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- Pregnancy rate [ Time Frame: One year after completion of endometriosis treatment (excision followed by 3 month of GnRH-analogues) ]
- 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
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
|Contact: Rudy L De Wilde, Professor||+49 441 229 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Rudy L De Wilde, Professor|
|Principal Investigator:||Rudy L De Wilde, Professor||Pius-Hospital Oldenburg, Department of Gynecology, Obstetrics and Gynecological Oncology|