Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-10 @ 4:54 AM
Study NCT ID:
NCT01989260
Status:
UNKNOWN
Last Update Posted:
2013-11-20
First Post:
2013-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-operative Ovarian Adhesion Study in Women With Endometriosis
Sponsor:
University College London Hospitals
Organization:
Study Overview
Official Title:
Effectiveness of Anti-adhesive Gel in Preventing Post Operative Ovarian Adhesions in Women With Pelvic Endometriosis: A Double Blind Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2013-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: