An observational study in Oncology, Fertility Issues and Surgery, sponsored by Regina Elena Cancer Institute. Completed at 1 site in Italy. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-24.
Sponsored by Regina Elena Cancer Institute · Observational
To compare surgical outcomes of oncologic patients that underwent conventional laparoscopy and percutaneous laparoscopy for cryopreservation of ovarian tissue.
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.
9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 59 is below the median of 202 across 1,742 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Regina Elena Cancer Institute is the lead sponsor of 94 studies on the registry; 51 are open to participants now.
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Women with histological diagnosis of malignancy during reproductive age undergoing ovarian tissue explant for ovarian tissue cryopreservation, from Aug 2017 to Jun 2021.
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Exclusion Criteria:
Laparoscopy with percutaneous grasp (2.9 mm).
Device: Ovaian tissue explant
Conventional laparoscopy with conventional laparoscopic trocars (10 or 5 mm).
Device: Ovaian tissue explant
Ovarian tissue explant for cryopreservation of ovarian tissue
Post-operative pain
Post-operative pain is evaluated with VAS score ranging from 1 to 10 (higher score, maximum pain)
Time frame: 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".
Time frame: minimum 3 months after surgery
Recovery time
Time from surgical intervention to discharge in days
Time frame: Days
Operative time
Time of operation in minutes
Time frame: 1 day
Blood loss
Entity of blood loss during surgery in ml
Time frame: 1 day
Surgical complications
The presence of absence of intra and post-operative complications (yes or not and type)
Time frame: 30 days
Ran from May 2021 to primary completion in Jul 2021, 1 month.
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Regina Elena Cancer Institute