Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation.

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

Detailed Description
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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.

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

Conditions
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Oncology, Fertility Issues, Surgery

Intervention / Treatment
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* Device: Ovaian tissue explant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Oncologic women with desire to preserve fertility Exclusion Criteria: Ovarian explant with different techniques than laparoscopy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Percutaneous laparoscopy<br>Laparoscopy with percutaneous grasp (2.9 mm). | Device: Ovaian tissue explant<br>* Ovarian tissue explant for cryopreservation of ovarian tissue<br>|
| Conventional laparoscopy<br>Conventional laparoscopy with conventional laparoscopic trocars (10 or 5 mm). | Device: Ovaian tissue explant<br>* Ovarian tissue explant for cryopreservation of ovarian tissue<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percuvataneous laparoscopy, Ovarian Tissue Cryopreservation