Post-operative Ovarian Adhesion Study in Women With Endometriosis

Endometriosis Clinical Trial

Official title:

Effectiveness of Anti-adhesive Gel in Preventing Post Operative Ovarian Adhesions in Women With Pelvic Endometriosis: A Double Blind Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01989260
• Other study ID #: 13/0055
• Secondary ID: BS12-00079613/LO
• Status: Not yet recruiting
• Phase: N/A
• First received: November 14, 2013
• Last updated: November 14, 2013
• Start date: December 2013
• Est. completion date: April 2015

Study information

• Verified date: November 2013
• Source: University College London Hospitals
• Contact: Katie Pateman
• Email: katie.pateman[@]uclh.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endometriosis

Intervention

Device:
• Anti-adhesive gel
4mls of anti-adhesive gel coated to the randomized ovary

Locations

Country	Name	City	State
United Kingdom	University College London Hospital	London	England

Sponsors (2)

Lead Sponsor	Collaborator
University College London Hospitals	Baxter BioScience

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The presence, intensity and site of post operative pain		Assessed at 3 months post-operative review	No