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Post-operative Ovarian Adhesion Study in Women With Endometriosis

NCT ID: NCT01989260

Last Updated: 2013-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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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

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Endometriosis

Keywords

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Anti-adhesive gel

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.

Group Type OTHER

Anti-adhesive gel

Intervention Type DEVICE

4mls of anti-adhesive gel coated to the randomized ovary

Interventions

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Anti-adhesive gel

4mls of anti-adhesive gel coated to the randomized ovary

Intervention Type DEVICE

Other Intervention Names

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Baxter BioScience CoSeal Surgical Sealant CE 0123

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Baxter BioScience

INDUSTRY

Sponsor Role collaborator

University College London Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Katie Pateman

Medical Doctor: Clinical Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Davor Jurkovic

Role: STUDY_DIRECTOR

University College London Hospital

Ertan Saridogan

Role: STUDY_CHAIR

University College London Hospital

Alfred Cutner

Role: STUDY_CHAIR

University College London Hospital

George Pandis

Role: STUDY_CHAIR

University College London Hospital

Locations

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University College London Hospital

London, England, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Katie Pateman

Role: CONTACT

Email: [email protected]

Davor Jurkovic

Role: CONTACT

Email: [email protected]

Facility Contacts

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Katie Pateman

Role: primary

Davor Jurkovic

Role: backup

Other Identifiers

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BS12-000796

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

13/LO/0853

Identifier Type: OTHER

Identifier Source: secondary_id

13/0055

Identifier Type: -

Identifier Source: org_study_id