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Post-operative Ovarian Adhesion Study in Women With Endometriosis

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ClinicalTrials.gov Identifier: NCT01989260
Recruitment Status : Unknown
Verified November 2013 by Katie Pateman, University College London Hospitals.
Recruitment status was:  Not yet recruiting
First Posted : November 20, 2013
Last Update Posted : November 20, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment
Endometriosis Device: Anti-adhesive gel

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Anti-adhesive Gel in Preventing Post Operative Ovarian Adhesions in Women With Pelvic Endometriosis: A Double Blind Randomized Controlled Trial
Study Start Date : December 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Device: Anti-adhesive gel
4mls of anti-adhesive gel coated to the randomized ovary
Other Names:
  • Baxter BioScience
  • CoSeal Surgical Sealant
  • CE 0123


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The presence, intensity and site of post operative pain [ Time Frame: Assessed at 3 months post-operative review ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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): NCT01989260


Contacts
Contact: Katie Pateman katie.pateman@uclh.nhs.uk
Contact: Davor Jurkovic jurkovic.davor@uclh.nhs.uk

Locations
United Kingdom
University College London Hospital Not yet recruiting
London, England, United Kingdom, NW1 2BU
Contact: Katie Pateman       katie.pateman@uclh.nhs.uk   
Contact: Davor Jurkovic       davor.jurkovic@uclh.nhs.uk   
Principal Investigator: Katie Pateman         
Principal Investigator: Davor Jurkovic         
Sub-Investigator: Alfred Cutner         
Sub-Investigator: Ertan Saridogan         
Sub-Investigator: George Pandis         
Sub-Investigator: Tom Holland         
Sponsors and Collaborators
University College London Hospitals
Baxter BioScience
Investigators
Study Director: Davor Jurkovic University College London Hospital
Study Chair: Ertan Saridogan University College London Hospital
Study Chair: Alfred Cutner University College London Hospital
Study Chair: George Pandis University College London Hospital
More Information

Responsible Party: Katie Pateman, Medical Doctor: Clinical Research Fellow, University College London Hospitals
ClinicalTrials.gov Identifier: NCT01989260     History of Changes
Other Study ID Numbers: 13/0055
BS12-000796 ( Other Grant/Funding Number: Baxter BioScience )
13/LO/0853 ( Other Identifier: NHS REC )
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: November 20, 2013
Last Verified: November 2013

Keywords provided by Katie Pateman, University College London Hospitals:
Endometriosis

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female