Post-operative Ovarian Adhesion Study in Women With Endometriosis

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.

Study Overview

• Status: Unknown
• Conditions: Endometriosis
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katie Pateman; Email: katie.pateman@uclh.nhs.uk
• Study Contact Backup: Name: Davor Jurkovic; Email: jurkovic.davor@uclh.nhs.uk

Study Locations

• United Kingdom
  • England
    • London, England, United Kingdom, NW1 2BU
      • University College London Hospital
      • Contact: Katie Pateman; Email: katie.pateman@uclh.nhs.uk
      • Contact: Davor Jurkovic; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: TRIPLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
The presence, intensity and site of post operative pain	Assessed at 3 months post-operative review

Collaborators and Investigators

• Sponsor: University College London Hospitals
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ANTICIPATED): April 1, 2015
• Study Completion (ANTICIPATED): April 1, 2015

Study Registration Dates

• First Submitted: November 14, 2013
• First Submitted That Met QC Criteria: November 14, 2013
• First Posted (ESTIMATE): November 20, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 20, 2013
• Last Update Submitted That Met QC Criteria: November 14, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Endometriosis
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 13/0055; BS12-000796 (OTHER_GRANT: Baxter BioScience); 13/LO/0853 (OTHER: NHS REC)