Suture of the Ovary After Enucleation of Ovarian Endometrioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2027-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometrioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Surgeons who perform the surgery will be not masked for the treatment allocation.

Evaluators (sonographers, data analyzers) will be blind for the treatment allocation.

Study Groups

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Suture

Women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas.

Group Type EXPERIMENTAL

Suture of the ovarian cortex

Intervention Type PROCEDURE

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).

No suture

Women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.

Group Type SHAM_COMPARATOR

No suture of the ovarian cortex

Intervention Type PROCEDURE

Laparoscopic enucleation of endometriomas without suture of the ovarian cortex

Interventions

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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).

Intervention Type PROCEDURE

No suture of the ovarian cortex

Laparoscopic enucleation of endometriomas without suture of the ovarian cortex

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women affected by one primary (no recurrent) monolateral ovarian endometrioma, with maximum diameter between 5 and 10 cm, undergoing laparoscopic enucleation by stripping technique;
* Normal AFC at the enrollment (baseline).

Exclusion Criteria

* Any other disease;
* Bilateral endometriomas;
* Deep infiltrating endometriosis;
* No previous pelvic surgery (even not gynecological);
* Any other pharmacologic and non pharmacologic treatment in the previous 3 months (wash-out period);

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No