Synthetic haemostatic agent at laparoscopic ovarian cystectomy: STASIS study

Synthetic haemostatic agent at laparoscopic ovarian cystectomy on ovarian reserve in women aged 25 to 40 years: STASIS study

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623001194651

Enrollment

100

Registered

2023-11-17

Start date

2024-01-01

Completion date

2024-06-01

Last updated

2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Synthetic haemostatic agent at laparoscopic ovarian cystectomy on ovarian reserve in women aged 25 to 40 years: STASIS study Ovarian cysts are a common gynaecological issue facing reproductive age women and the good standard surgical management is laparoscopic (key hole) ovarian cystectomy (removal of cyst). This procedure can associated with bleeding. Traditional methods to stop bleeding can damage the normal ovary (ovarian reserve) and potentially impact future fertility. Hameostatic (blood clotting) agents are commonly used surgical products applied to the ovary after the cyst has been removed to treat bleeding in a way that minimises damage to the normal ovary. Current available products are human or animal derived. Purastat is a similar product but completely synthetic (does not contain human or animal products), used in Gastrointestinal procedures (colonoscopy and gastroscopy) and is effective in reducing complications related to blood loss. We would like to study if applying this product to the ovary after the time of laparoscopy ovarian cystectomy is protective for ovarian reserve and future fertility.

Interventions

Synthetic haemostatic agent RADA16 (2.5% concentration, 3ml or 5ml prefill syringe as determined by surgical team) will be applied to surgical site following ovarian cystectomy until haemostasis is achieved.and then left in place Administrated by gynaecological surgeon intra-operative data including adherence of intervention will be collected by the surgical team completing STASIS study data collection form at end of procedure

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

25 Years to 40 Years

Healthy volunteers

Inclusion criteria

• Age 25-40 years • Waitlisted for elective laparoscopic ovarian cystectomy • Primary diagnosis of unilateral or bilateral ovarian cyst as diagnosed on pelvic ultrasound scan • Premenopausal with regular menstrual cycle • Able to provide informed consent with or without an interpreter

Exclusion criteria

• History of allergy to haemostatic agents • Post-menopausal status • Pregnancy of lactation • Suspicious findings for ovarian malignancy • History of ovarian surgery (same ovary) • Previous hysterectomy • Active pelvic infection • Unable to provide informed consent

Outcome results