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| ID | Type | Description | Link |
|---|---|---|---|
| BS12-000796 | Other Grant/Funding Number | Baxter BioScience | |
| 13/LO/0853 | Other Identifier | NHS REC |
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| Name | Class |
|---|---|
| Baxter BioScience | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-adhesive gel | Device | 4mls of anti-adhesive gel coated to the randomized ovary |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Ultrasound assessment 3 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The presence, intensity and site of post operative pain | Assessed at 3 months post-operative review |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katie Pateman | Contact | katie.pateman@uclh.nhs.uk | ||
| Davor Jurkovic | Contact | jurkovic.davor@uclh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Davor Jurkovic | University College London Hospitals | Study Director |
| Ertan Saridogan | University College London Hospitals | Study Chair |
| Alfred Cutner |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London Hospital | London | England | NW1 2BU | United Kingdom |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| University College London Hospitals |
| Study Chair |
| George Pandis | University College London Hospitals | Study Chair |
| D000091662 | Genital Diseases |