Post-operative Ovarian Adhesion Study in Women With Endometriosis

NCT01989260 | Unknown DMC

• 3 other identifiers: 13/0055BS12-00079613/LO/0853
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The presence, intensity and site of post operative pain

  Assessed at 3 months post-operative review

Study Arms (1)

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.

Device: Anti-adhesive gel

Interventions

Anti-adhesive gel DEVICE

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

Also known as: Baxter BioScience, CoSeal Surgical Sealant, CE 0123

Anti-adhesive gel

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College London Hospitals: lead
• Baxter BioScience: collaborator

Study Sites (1)

University College London Hospital

London, England, NW1 2BU, United Kingdom

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Davor Jurkovic

  University College London Hospital

  STUDY DIRECTOR

• Ertan Saridogan

  University College London Hospital

  STUDY CHAIR

• Alfred Cutner

  University College London Hospital

  STUDY CHAIR

• George Pandis

  University College London Hospital

  STUDY CHAIR

Central Study Contacts

Katie Pateman

CONTACT

katie.pateman@uclh.nhs.uk

Davor Jurkovic

CONTACT

jurkovic.davor@uclh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor: Clinical Research Fellow

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 20, 2013
• Study Start: December 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

GB (1)