EndometriosisNCT01989260
Post-operative Ovarian Adhesion Study in Women With Endometriosis
A study testing Anti-adhesive gel in people with Endometriosis, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
Endometriosis is a common gynaecological condition which typically present with pelvic pain and fertility problems. It is caused by tissues which are similar to the lining of the womb growing inside the women's pelvis. Severe endometriosis is most effectively treated using keyhole surgery. Read more about this study
- Who is it for?
- Ages 19 to 55 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Anti-adhesive gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2013to Apr 2015
- Phase
- Interventional
- 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 19 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged between 19-55 years
- diagnosed with severe endometriosis on pre-operative transvaginal ultrasound
- severe endometriosis diagnosed in the surgical context is the opening of one or both para-rectal spaces
Who cannot join
- inability/unwillingness to provide written consent
- inability to tolerate a transvaginal ultrasound scan
- complications at surgery such as unplanned oophorectomies, bowel injuries or conversion to open surgery
Trial locations and contacts
1 site in 1 country.
Katie Pateman contact
Davor Jurkovic contact
United Kingdom1 site
University College London Hospital
London, England, NW1 2BU
Katie Pateman, katie.pateman@uclh.nhs.uk
Davor Jurkovic, davor.jurkovic@uclh.nhs.uk
About this study
Official title: Effectiveness of Anti-adhesive Gel in Preventing Post Operative Ovarian Adhesions in Women With Pelvic Endometriosis: A Double Blind Randomized Controlled Trial
Endometriosis is a common gynaecological condition which typically present with pelvic pain and fertility problems. It is caused by tissues which are similar to the lining of the womb growing inside the women's pelvis. Severe endometriosis is most effectively treated using keyhole surgery. During the operation, endometriosis tissue is removed. However, following successful removal of endometriosis, women may still experience pain because the ovaries sometimes become stuck to the bottom of the pelvis due to post-operative scarring. We want to see if coating one of the ovaries in an anti-scar tissue gel stops the post-operative scarring.
Read the detailed description
Endometriosis is a common benign condition, affecting women of reproductive age. The disorder is characterized by endometrial surface epithelium, endometrial glands or stroma, found outside the uterus at anatomically ectopic sites.
- Laparoscopic excision of the disease is frequently carried out for the treatment of severe endometriosis. Pelvic adhesions often develop following surgery, restricting the success of treatment. Commercially available anti-adhesive solutions are often used successfully for limiting post-operative adhesions following myomectomy surgery.
- This study aims to assess the effect of resorbable hydrogel anti-adhesive gel following laparoscopic surgery for severe pelvic endometriosis on the prevalence of postoperative ovarian adhesions.
- This is a prospective double blind randomized controlled trial for patients with severe pelvic endometriosis (as defined by the American Society for Reproductive Medicine classification system) requiring extensive laparoscopic dissection (open of one or both para-rectal spaces) with uterine and ovarian preservation.
- Disease severity and eligibility for inclusion into the study will be confirmed at surgery.
- Pre-operatively, all participants will complete a standardized symptom questionnaire detailing the presence and intensity of specific endometriosis symptoms Intra-operatively both ovaries are routinely elevated to the anterior abdominal wall using Prolene suture (ovarian suspension) to facilitate operative access. At the end of the procedure, each participant will be randomized to having only one ovary coated with 4mls of hydrogel anti-adhesive gel, before the ovaries are replaced to their anatomically correct position.
- Three months after surgery, all randomized patients will have a transvaginal ultrasound scan to assess for ovarian mobility and repeat symptom questionnaire.
- Both patients and the person performing the ultrasound scan will be blinded to the randomization process.
- Conditions
- Endometriosis
- Being tested
- Anti-adhesive gel
- Keywords
- Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-adhesive gelDevice
Also called Baxter BioScience, CoSeal Surgical Sealant, CE 0123
4mls of anti-adhesive gel coated to the randomized ovary
| Study group | Role | What they receive |
|---|---|---|
| Anti-adhesive gel | Other | An anti-adhesive gel will be administered to one ovary (randomised at the time of laparoscopic surgery to severe endometriosis). The coated ovary will be compared to the non-coated ovary 3 months after surgery to assess for the presence of post-operative ovarian adhesions. Neither the patient nor the person performing the ultrasound scan assessing for the presence of ovarian adhesions will know which was the ovary coated in the anti-adhesive gel. Receives: Device: Anti-adhesive gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of ovarian adhesions diagnosed by ultrasound after laparoscopic surgery
The primary outcome measure is the prevalence of ovarian adhesions diagnosed by ultrasound assessment after surgery. The presence of ovarian adhesions will be assessed by a combination of gentle pressure with the vaginal probe and abdominal pressure with the examiner's free hand as in a bimanual examination. The prevalence of ovarian adhesions will be diagnosed when the ovarian mobility is restricted and the ovary cannot be separated from the peritoneum of the lateral pelvic side wall and/or pouch of Douglas.
Measured: Ultrasound assessment 3 months post-surgery
Secondary outcomes (1)
The presence, intensity and site of post operative pain
Measured: Assessed at 3 months post-operative review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter BioScience
- Responsible party
- Principal investigator, Katie Pateman, University College London Hospitals
- Investigators
- Davor Jurkovic, Study director, University College London HospitalsErtan Saridogan, Study chair, University College London HospitalsAlfred Cutner, Study chair, University College London HospitalsGeorge Pandis, Study chair, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989260
- Sponsor's protocol ID
- 13/0055
- Other IDs
- BS12-000796, 13/LO/0853
- Status last verified
- Nov 2013
- First submitted
- 14 Nov 2013
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Anti-adhesive Gel in Preventing Post Operative Ovarian Adhesions in Women With Pelvic Endometriosis: A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01989260
- Acronym / sponsor ID
- 13/0055
- Conditions
- Endometriosis
- Keywords
- Endometriosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Collaborators
- Baxter BioScience
- Study start
- Dec 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 20 Nov 2013 (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 gynaecological condition which typically present with pelvic pain and fertility problems. It is caused by tissues which are similar to the lining of the womb growing inside the women's pelvis. Severe endometriosis is most effectively treated using keyhole surgery. During the operation, endometriosis tissue is removed. However, following successful removal of endometriosis, women may still experience pain because the ovaries sometimes become stuck to the bottom of the pelvis due to post-operative scarring. We want to see if coating one of the ovaries in an anti-scar tissue gel stops the post-operative scarring.
Detailed description
Endometriosis is a common benign condition, affecting women of reproductive age. The disorder is characterized by endometrial surface epithelium, endometrial glands or stroma, found outside the uterus at anatomically ectopic sites.
- Laparoscopic excision of the disease is frequently carried out for the treatment of severe endometriosis. Pelvic adhesions often develop following surgery, restricting the success of treatment. Commercially available anti-adhesive solutions are often used successfully for limiting post-operative adhesions following myomectomy surgery.
- This study aims to assess the effect of resorbable hydrogel anti-adhesive gel following laparoscopic surgery for severe pelvic endometriosis on the prevalence of postoperative ovarian adhesions.
- This is a prospective double blind randomized controlled trial for patients with severe pelvic endometriosis (as defined by the American Society for Reproductive Medicine classification system) requiring extensive laparoscopic dissection (open of one or both para-rectal spaces) with uterine and ovarian preservation.
- Disease severity and eligibility for inclusion into the study will be confirmed at surgery.
- Pre-operatively, all participants will complete a standardized symptom questionnaire detailing the presence and intensity of specific endometriosis symptoms Intra-operatively both ovaries are routinely elevated to the anterior abdominal wall using Prolene suture (ovarian suspension) to facilitate operative access. At the end of the procedure, each participant will be randomized to having only one ovary coated with 4mls of hydrogel anti-adhesive gel, before the ovaries are replaced to their anatomically correct position.
- Three months after surgery, all randomized patients will have a transvaginal ultrasound scan to assess for ovarian mobility and repeat symptom questionnaire.
- Both patients and the person performing the ultrasound scan will be blinded to the randomization process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-adhesive gel | Other | Device: Anti-adhesive gelAn anti-adhesive gel will be administered to one ovary (randomised at the time of laparoscopic surgery to severe endometriosis). The coated ovary will be compared to the non-coated ovary 3 months after surgery to assess for the presence of post-operative ovarian adhesions. Neither the patient nor the person performing the ultrasound scan assessing for the presence of ovarian adhesions will know which was the ovary coated in the anti-adhesive gel. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged between 19-55 years
- diagnosed with severe endometriosis on pre-operative transvaginal ultrasound
- severe endometriosis diagnosed in the surgical context is the opening of one or both para-rectal spaces
Key exclusion criteria (3 listed)
- inability/unwillingness to provide written consent
- inability to tolerate a transvaginal ultrasound scan
- complications at surgery such as unplanned oophorectomies, bowel injuries or conversion to open surgery
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 |
|---|---|---|
| Anti-adhesive gelAlso: Baxter BioScience, CoSeal Surgical Sealant, CE 01234mls of anti-adhesive gel coated to the randomized ovary | Device | Anti-adhesive gel |
Primary outcome
The prevalence of ovarian adhesions diagnosed by ultrasound after laparoscopic surgery
Time frame: Ultrasound assessment 3 months post-surgery
The primary outcome measure is the prevalence of ovarian adhesions diagnosed by ultrasound assessment after surgery. The presence of ovarian adhesions will be assessed by a combination of gentle pressure with the vaginal probe and abdominal pressure with the examiner's free hand as in a bimanual examination. The prevalence of ovarian adhesions will be diagnosed when the ovarian mobility is restricted and the ovary cannot be separated from the peritoneum of the lateral pelvic side wall and/or pouch of Douglas.
1 secondary outcome
The presence, intensity and site of post operative pain
Time frame: Assessed at 3 months post-operative review
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
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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.
Katie Pateman contact
Davor Jurkovic contact
Davor Jurkovic study director
University College London Hospitals
Ertan Saridogan study chair
University College London Hospitals
Alfred Cutner study chair
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-adhesive gel in people with Endometriosis, run by University College London Hospitals at 1 site in United Kingdom.
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 3 inclusion and 3 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 20 Nov 2013. 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 United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Katie Pateman (katie.pateman@uclh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of ovarian adhesions diagnosed by ultrasound after laparoscopic surgery (time frame: Ultrasound assessment 3 months post-surgery). 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 20 Nov 2013.