None listed
Conditions
Brief summary
Endometriosis is a common inflammatory condition affecting women during their reproductive years, with potentially debilitating sequelae in the form of subfertility and chronic pain. Endometriomas are common, occurring in up to 44% of endometriosis cases. Surgical cyst excision is the mainstay treatment for endometriomas, however surgery is often detrimental to ovarian reserve. Conventional technique using manual stripping of endometriotic cyst from the ovarian cortex is commonly associated with inadvertent removal of healthy ovarian tissue. Therefore, current standard surgical treatment of endometriomas carries the caveat of further contributing to the fertility burden of patients, in whom ovarian reserve might already be compromised. A surgical technique using vasopressin has been shown to result in reduction in the need for bipolar diathermy in several small studies. This promising benefit of VIT also appeared to improve post-surgery ovarian reserve in one study. However, the data on the proposed benefits of this technique remains limited in the literature. Therefore, given the clear need for a less damaging surgical approach than standard approaches and the dearth in the literature of evidence of the efficacy of the use of vasopressin for the excision of endometrioma, we seek to elucidate the purported usefulness of this technique for the treatment of endometrioma and its potential benefit on ovarian reserve and endometriosis-related quality of life.
Interventions
Consenting patients who have been randomly allocated to the treatment group will undergo laparoscopic excision of their endometriosis cyst (endometrioma) using the vasopressin hydrodissection (VIT) technique. Following incision and drainage of the cyst content, diluted vasopressin (0.5mL per 100mL normal saline) is injected into the interface/plane between the endometrioma and the ovarian parenchyma, for the purpose of hydrodissection. The endometrioma is then separated from the ovarian parenchy
Consenting patients who have been randomly allocated to the treatment group will undergo laparoscopic excision of their endometriosis cyst (endometrioma) using the vasopressin hydrodissection (VIT) technique. Following incision and drainage of the cyst content, diluted vasopressin (0.5mL per 100mL normal saline) is injected into the interface/plane between the endometrioma and the ovarian parenchyma, for the purpose of hydrodissection. The endometrioma is then separated from the ovarian parenchyma using standard 'stripping' technique, and haemostasis is checked and carried out either by bipolar diathermy or ovarian suturing, as per standard surgical practice. Based on current literature and anecdotal data, the anticipated duration of vasopressin hydrodissection will be less than the standard technique; the extent of this will depend on the size of the endometrioma and surgical factors such as bleeding. All procedures will be carried out at St George Private Hospital by laparoscopic surgeons affiliated with the Sydney Women's Endosurgery Centre (SWEC); all of whom have undergone formal advanced surgical training with at least 10 years of surgical experience. All surgeries will be recorded via the laparoscopic camera and the film reviewed by an independent surgeon who is not involved in the surgery to avoid bias.
Sponsors
Sydney Women's Endosurgery Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Women undergoing laparoscopic removal of endometrioma.
Exclusion criteria
Women who have significant medical conditions such as: hypertension, cardiac disease, diabetes mellitus, severe renal or hepatic disease; or women who have previously participated in this trial; or those with hypersensitivity to vasopressin.
Outcome results
None listed