EndometriosisPhase 4NCT02165917
Study to Compare Peritoneal Ablation by Excision Only and Excision With the Use of an Adhesion Barrier
A Phase 4 study testing Excision plus hyaluronic acid gel and Excision only in people with Endometriosis, run by Pius-Hospital Oldenburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Excision plus hyaluronic acid gel and Excision only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Pius-Hospital, Department of Gynecology, Obstetrics and Gynecological Oncology, Carl von Ossietzky University
Oldenburg, Lower Saxony, 26121
Rudy L De Wilde, Professor, +49 441 229 1501, gyn-sekretariat@pius-hospital.de
Rudy L De Wilde, Professor
About this study
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
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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- Excision plus hyaluronic acid gel, Excision only
- Keywords
- Endometriosis, Adhesions, Hyalobarrier®, Hyaluronic acid, Antiadhesion agent, Adhesionbarrier, Pregnancy rate
- Medical subject headings
- Endometriosis, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excision plus hyaluronic acid gelProcedure or surgery
Excision of endometriosis foci by laparoscopic standard methods followed by an application of 10 cc Hyaluronic acid gel, in order to prevent postsurgical adhesions.
Excision onlyProcedure or surgery
Excision of endometriosis foci by laparoscopic standard methods only.
| Study group | Role | What they receive |
|---|---|---|
| Excision only | Placebo comparator | Laparoscopic excision of endometriotic lesions followed by 3 month of GnRH-Analogue administration Receives: Procedure: Excision only |
| Excision plus hyaluronic acid gel | Active comparator | 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 Receives: Procedure: Excision plus hyaluronic acid gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: One year after completion of endometriosis treatment (excision followed by 3 month of GnRH-analogues)
Secondary outcomes (2)
Endometriosis-associated pain
Outcome measure is measured by visual analogue scale
Measured: The day before laparoscopy is performed
Endometriosis-associated pain
Outcome measure is measured by visual analogue scale
Measured: One year after completion of endometriosis treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startMay 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pius-Hospital Oldenburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Dr. med. Rudy Leon De Wilde, Pius-Hospital Oldenburg
- Investigators
- Rudy L De Wilde, Professor, Principal investigator, Pius-Hospital Oldenburg, Department of Gynecology, Obstetrics and Gynecological Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165917
- Sponsor's protocol ID
- PHDW-003
- Status last verified
- Nov 2015
- First submitted
- 15 Apr 2014
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02165917
- Acronym / sponsor ID
- PHDW-003
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Adhesions, Hyalobarrier®, Hyaluronic acid, Antiadhesion agent, Adhesionbarrier, Pregnancy rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pius-Hospital OldenburgUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Excision only | Placebo comparator | Procedure: Excision onlyLaparoscopic excision of endometriotic lesions followed by 3 month of GnRH-Analogue administration |
| Excision plus hyaluronic acid gel | Active comparator | Procedure: Excision plus hyaluronic acid gelStandard Laparoscopic excision of endometriotic lesions plus application of 10 cc of a hyaluronic acid gel (Hyalobarrier® ), followed by 3 month of GnRH-analogue administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excision plus hyaluronic acid gelExcision of endometriosis foci by laparoscopic standard methods followed by an application of 10 cc Hyaluronic acid gel, in order to prevent postsurgical adhesions. | Procedure or surgery | Excision plus hyaluronic acid gel |
| Excision onlyExcision of endometriosis foci by laparoscopic standard methods only. | Procedure or surgery | Excision only |
Primary outcome
Pregnancy rate
Time frame: One year after completion of endometriosis treatment (excision followed by 3 month of GnRH-analogues)
2 secondary outcomes
Endometriosis-associated pain
Time frame: The day before laparoscopy is performed
Endometriosis-associated pain
Time frame: One year after completion of endometriosis treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
Related trials for Endometriosis
Not yet recruiting
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Endometriosis, Quality of Life
RecruitingPhase 1
Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis
Endometriosis
Active, not recruiting
Feasibility of a Mindfulness Intervention for Endometriosis Surgery
Endometriosis, Pain
Recruiting
Trial Evaluating Nutritional Fiber in Digestive Symptoms of Endometriosis
Endometriosis, Microbiome Dysbiosis
RecruitingObservational study
Retinal Imaging for Systemic Inflammation in Endometriosis
Endometriosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudy L De Wilde, Professor principal investigator
Pius-Hospital Oldenburg, Department of Gynecology, Obstetrics and Gynecological Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Excision plus hyaluronic acid gel and Excision only in people with Endometriosis, run by Pius-Hospital Oldenburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rudy L De Wilde, Professor (+49 441 229 1501, gyn-sekretariat@pius-hospital.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: One year after completion of endometriosis treatment (excision followed by 3 month of GnRH-analogues)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.