Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation.

November 15, 2021 updated by: Benito Chiofalo, Regina Elena Cancer Institute

Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation: a Single-center Experience.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00144
        • IRCCS "Regina Elena" National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women with histological diagnosis of malignancy during reproductive age undergoing ovarian tissue explant for ovarian tissue cryopreservation, from Aug 2017 to Jun 2021.

Description

Inclusion Criteria:

  • Oncologic women with desire to preserve fertility

Exclusion Criteria:

  • Ovarian explant with different techniques than laparoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Percutaneous laparoscopy
Laparoscopy with percutaneous grasp (2.9 mm).
Device: Ovaian tissue explant
Ovarian tissue explant for cryopreservation of ovarian tissue
Conventional laparoscopy
Conventional laparoscopy with conventional laparoscopic trocars (10 or 5 mm).
Device: Ovaian tissue explant
Ovarian tissue explant for cryopreservation of ovarian tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
0-1 and 2 days after surgery
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".
minimum 3 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regina Elena Cancer Institute

Investigators

  • Principal Investigator: Benito Chiofalo, IRCCS "Regina Elena" National Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2021

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

November 15, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1514/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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