Trials / Not Yet Recruiting
Not Yet RecruitingNCT03788720
Suture of the Ovary After Enucleation of Ovarian Endometrioma
Comparison Between Suture of the Ovary Versus no Suture After Enucleation of Ovarian Endometrioma
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Università degli Studi dell'Insubria · Academic / Other
- Sex
- Female
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Not accepted
Summary
Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of ectopic endometrial-like tissue outside the uterine cavity. According to the most updated guidelines of the European Society of Human Reproduction and Embryology (ESHRE), infertile women with endometriomas smaller than 3 cm should be addressed directly to Assisted Reproduction Technology (ART); conversely, for infertile women with endometriomas larger than 3 cm, enucleation of ovarian endometriomas could be considered in order to improve reproductive outcomes (both spontaneous and ART pregnancy rate). To date, literature data do not allow to draw a firm conclusion about the best strategy to reduce ovarian damage during enucleation of ovarian endometriomas: in particular, investigators still lack robust evidence in order to choose between suturing the ovary or not after the enucleation. In this scenario, the aim of our the study will be to compare functional outcomes of the ovary in a group of women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas (cases) and a group of women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Suture of the ovarian cortex | Suture of the ovarian cortex after laparoscopic enucleation of endometriomas, using one single monofilament suture material, continuous suture technique with maximum 5 transfixion of the ovarian cortex and intracorporeal knots only (no extracorporeal knots). |
| PROCEDURE | No suture of the ovarian cortex | Laparoscopic enucleation of endometriomas without suture of the ovarian cortex |
Timeline
- Start date
- 2023-05-01
- Primary completion
- 2025-05-01
- Completion
- 2027-05-01
- First posted
- 2018-12-28
- Last updated
- 2021-04-29
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03788720. Inclusion in this directory is not an endorsement.