Synthetic haemostatic agent at laparoscopic ovarian cystectomy: STASIS study

Not Applicable

• Conditions: ovarian cyst; ovarian reserve; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12623001194651
• Lead Sponsor: Anna Brownson (primary investigator)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-17
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pelvic ultrasound scan antral follicle count 3 months [ Baseline (within 4 weeks of operation) and 3 months post operative ]

Secondary Outcome Measures

Name	Time	Method
Serum Anti-Mullarian hormone[ Baseline (within 4 weeks of operation) and 3 months post operative ];readmission - patient medical records [ 30 days post-operative];return to theatre - patient medical records [ 30 days post-operative];haemorrhage (>500mls) - patient medical records [ 30 days post-operative];infection - patient medical records [ 30 days post operative];rate of allergy/adverse reaction - patient medical records [ 30 days post operative]