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Clinical Trials/NCT05527002
NCT05527002CompletedNot Applicable

Thoracic Endometriosis: A Cohort Study

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 site in 1 country50 target enrollmentStarted: March 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Mean scores of the Short Form Survey, SF-12

Study Overview

Brief Summary

Endometriosis is defined as the presence of endometrial glands and stroma outside the uterine cavity. It is an estrogen-dependent chronic inflammatory disease. Estimates show that up to 10% of premenopausal women have endometriosis. The most frequent forms of endometriosis are superficial peritoneal implants, ovarian cysts and deep nodules or plaques. However, the pelvis is not the exclusive site of endometriotic lesions: endometriosis can also affect the diaphragm, the pleura and the lung. All these localizations are included in the spectrum of "thoracic endometriosis".

Thoracic endometriosis may present with cough, wheezing, catamenial pneumothorax, hemothorax, hemoptysis and pulmonary nodules. If the diaphragmatic pleura is also involved, catamenial periscapular or neck pain may be associated with irritation of the phrenic nerve. The symptoms of thoracic endometriosis generally have catamenial onset. Thoracic endometriosis rarely occurs isolated. It is considered a progression of pelvic endometriotic disease. Due to its varied presentation, diagnosis can be particularly difficult and often only identified due to clinical suspicion. The instrumental diagnosis of pneumothorax and catamenial hemothorax can be obtained by radiography or computerized axial tomography of the chest. Magnetic resonance imaging is to be preferred in case of diaphragmatic involvement. The gold standard remains exploratory laparoscopy, possibly accompanied by Video Assisted Thoracic Surgery (VATS).

The first-line treatment is hormone therapy, aimed at suppressing ovulation and also preventing the onset of relapses. GnRH analogues are very effective in reducing the painful symptoms associated with endometriosis, but are not superior to other first-line treatments available. Furthermore, the prolonged hypoestrogenism can cause menopausal symptoms and osteoporosis.

Surgery should be considered a second-line treatment in case of intolerance or ineffectiveness of medical therapy. The surgical approach is multidisciplinary and involves the endoscopist gynecologist and the thoracic surgeon expert in VATS.

The principal aim of the study is the retrospective evaluation of thoracic endometriosis cases in our clinic over the last 20 years in order to evaluate the effectiveness of medical and surgical treatments in terms of satisfaction of patients suffering from this clinical condition. The secondary aim is to investigate the pathogenetic aspects of this clinical condition.

Detailed Description

Endometriosis is defined as the presence of endometrial glands and stroma outside the uterine cavity. It is an estrogen-dependent chronic inflammatory disease, in which the ectopic endometrium grows and proliferate under the action of estradiol. Estimates show that up to 10% of premenopausal women and 35% to 50% of women with infertility, pelvic pain or both, have endometriosis.

The most frequent forms of endometriosis are superficial peritoneal implants, ovarian cysts (endometrioma) and deep nodules or plaques (which can individually involve and infiltrate the parametria, Douglas pouch, anterior rectal wall, posterior vaginal fornix, antero-uterine pouch, bladder detrusor, ureters and sigmoid colon).

However, the pelvis is not the exclusive site of endometriotic lesions: endometriosis can also be localized outside the pelvis, resulting in the implantation and growth of an ectopic endometrium and catamenial symptoms.

In the thoracic cavity endometriosis can affect the diaphragm, the pleura and, ultimately, the lung. All these localizations are included in the spectrum of "thoracic endometriosis".

Thoracic endometriosis may present with cough, wheezing, catamenial pneumothorax, hemothorax, hemoptysis and pulmonary nodules. If the diaphragmatic pleura is also involved, catamenial periscapular or neck pain may be associated with irritation of the phrenic nerve.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • women aged 18-50 years
  • women with a diagnosis of thoracic endometriosis, in the presence or absence of other endometriotic localizations
  • women referred to our tertiary-care endometriosis center " Fondazione IRCCS Ospedale Maggiore Policlinico", Milan, from 1 January 2000 to 01 March 2022.

Exclusion Criteria

  • the presence of concomitant diseases of the respiratory system
  • women who denied their consensus

Outcomes

Primary Outcomes

Mean scores of the Short Form Survey, SF-12

Time Frame: 10 years

The SF-12 health survey, developed from the original SF-36 questionnaire, is a well-known, validated, self-administered 12-item instrument. It measures health dimensions covering functional status, well-being, and overall health. Information from the 12 items is used to construct Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) measures, with higher scores indicating better health perception.

Number of patients greatly improved, much improved, minimally improved, unchanged, minimally worsened, very worsened and greatly worsened

Time Frame: 10 years

Patients' Global Impression of Change (PGIC) scale, a composed of seven levels (greatly improved, much improved, minimally improved, unchanged, minimally worsened, very worsened, greatly worsened) to evaluate the effectiveness of medical and surgical treatments for thoracic endometriosis.

Number of patients with none, mild, moderate, severe or very severe symptoms

Time Frame: 10 years

Patients' Global Impression of Severity (PGIS) scale, a scale consisting of five levels (none, mild, moderate, severe, very severe)

Number of patients very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied

Time Frame: 10 years

a five-level Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied) to evaluate the effectiveness of medical and surgical treatments for thoracic endometriosis.

Mean scores of HADS- Hospital Anxiety and Depression Scale

Time Frame: 10 years

The HADS questionnaire is a self-assessment mood scale specifically designed for use in non-psychiatric hospital outpatients to determine states of anxiety and depression. It comprises 14 questions, 7 for the anxiety subscale and 7 for the depression subscale. Lower scores indicate better psychological status

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Direzione Ginecologia

Clinical Professor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study Sites (1)

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