Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation.

Overview

To compare surgical outcomes of oncologic patients that underwent conventional laparoscopy and percutaneous laparoscopy for cryopreservation of ovarian tissue.

Full Title of Study: “Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation: a Single-center Experience.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: July 1, 2021

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.

Interventions

  • Device: Ovaian tissue explant
    • Ovarian tissue explant for cryopreservation of ovarian tissue

Arms, Groups and Cohorts

  • Percutaneous laparoscopy
    • Laparoscopy with percutaneous grasp (2.9 mm).
  • Conventional laparoscopy
    • Conventional laparoscopy with conventional laparoscopic trocars (10 or 5 mm).

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • 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”.

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Oncologic women with desire to preserve fertility Exclusion Criteria:

  • Ovarian explant with different techniques than laparoscopy

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 42 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Regina Elena Cancer Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Benito Chiofalo, Principal Investigator – Regina Elena Cancer Institute
  • Overall Official(s)
    • Benito Chiofalo, Principal Investigator, IRCCS “Regina Elena” National Cancer Institute

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.