Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation: a Single-center Experience.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Aesthetic outcomes
Study Overview
Brief Summary
To compare surgical outcomes of oncologic patients that underwent conventional laparoscopy and percutaneous laparoscopy for cryopreservation of ovarian tissue.
Detailed Description
This is a retrospective analysis to evaluate the efficacy and safety of percutaneous laparoscopy for the ovarian tissue explant in oncologic women. Surgical outcomes of patients that underwent percutaneous laparoscopy were compared with those of women that underwent conventional laparoscopy. Data from 2017 to 2021 were collected in a single Oncologic Center in Italy. The principal outcomes considered are post-operative pain, recovery time and aesthetic outcomes.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 42 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Oncologic women with desire to preserve fertility
Exclusion Criteria
- •Ovarian explant with different techniques than laparoscopy
Outcomes
Primary Outcomes
Aesthetic outcomes
Time Frame: minimum 3 months after surgery
General satisfaction regarding aesthetic outcomes is collected with a satisfaction survey. The score ranged from 1 to 5, with 1 indicating "very dissatisfied" and 5 "very satisfied".
Post-operative pain
Time Frame: 0-1 and 2 days after surgery
Post-operative pain is evaluated with VAS score ranging from 1 to 10 (higher score, maximum pain)
Secondary Outcomes
- Blood loss(1 day)
- Recovery time(Days)
- Surgical complications(30 days)
- Operative time(1 day)
Investigators
Benito Chiofalo
Principal Investigator
Regina Elena Cancer Institute