Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation.

Completed

• Conditions: Surgery; Oncology; Fertility Issues
• Interventions: Device: Ovaian tissue explant

• Registration Number: NCT05134090
• Lead Sponsor: Regina Elena Cancer Institute

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 Timeline

• Study Start: 2021-05-10
• Primary Completion: 2021-07-01
• Study Completion: 2021-08-01
• Study First Submitted: 2021-08-11
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-15
• Last Update Submitted: 2021-11-15
• Study First Posted: 2021-11-24
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

Inclusion Criteria

• Oncologic women with desire to preserve fertility

Exclusion Criteria

• Ovarian explant with different techniques than laparoscopy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Percutaneous laparoscopy	Ovaian tissue explant	Laparoscopy with percutaneous grasp (2.9 mm).
Conventional laparoscopy	Ovaian tissue explant	Conventional laparoscopy with conventional laparoscopic trocars (10 or 5 mm).

Primary Outcome Measures

Name	Time	Method
Aesthetic outcomes	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	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 Outcome Measures

Name	Time	Method
Blood loss	1 day	Entity of blood loss during surgery in ml
Recovery time	Days	Time from surgical intervention to discharge in days
Surgical complications	30 days	The presence of absence of intra and post-operative complications (yes or not and type)
Operative time	1 day	Time of operation in minutes

Trial Locations

Locations (1)

IRCCS "Regina Elena" National Cancer Institute; 🇮🇹 Rome, Lazio, Italy