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Endometriosis clinical trials

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NCT ID: NCT04711408 Recruiting - Chronic Pain Clinical Trials

Virtual Reality During Ultrasound Examination of Women With Endometriosis

Start date: June 14, 2022
Phase: N/A
Study type: Interventional

To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during ultrasound exam in patients with endometriosis in the outpatient setting.

NCT ID: NCT04704115 Recruiting - Endometrioma Clinical Trials

The Therapy of Large Endometrioma

ENDOKYSTE
Start date: January 21, 2021
Phase:
Study type: Observational

Endometrioma's prevalence is between 23 and 55%. It causes pelvic pain, decrease fertility and ovarian reserve. Currently, there's no recommendation about large endometrioma's treatment and there's no information on the best treatment to limit recurrences, preserve fertility and ovarian reserve. In Lille university hospital, simple laparoscopic drainage associated with hormonal therapy is practiced to reduce the risk of cystectomy. This protocol will be evaluated with an observational and prospective study, including women of childbearing age having endometrioma measuring 6 cm or above. The aim of this study is to assess if cyst drainage associated with GnRH agonist, could decrease endometrioma recurrences, deleterious effect on ovarian reserve and evaluate impact on anti-mullerian hormone

NCT ID: NCT04671004 Recruiting - Clinical trials for Endometriosis, Parametrium, Surgery

The "Concept" of Parametria in the Treatment of Deep Infiltrating Endometriosis

Start date: June 1, 2020
Phase:
Study type: Observational

Background Deep infiltrating endometriosis (DIE) is most commonly located at the uterosacral ligaments, rectovaginal septum, pararectal space and vesicouterine fold. A nodule within the uterosacral ligaments (i.e involvement of the dorsal parametrium), increases the complexity of surgical resection. Parametrial involvement in DIE cases occurs in 25% of patients with severe endometriosis, possibly with hypogastric/sacral plexus or sciatic nerve involvement. The bladder functional impairment, after surgery for DIE involved the parametria, may vary between the 6.5% to 32.8%. Preservation of the hypogastric and pelvic splanchnic nerves represents the key aspect in pelvic surgery to prevent postoperative voiding disfunction. Several techniques for the excision of DIE have been described, but large, prospective RCTs are lacking. In particular, a clear standardization of the parametrectomy for DIE is missing. Systematic reviews on the surgical treatment of DIE demonstrated that it is impossible to compare the literature about the parametrectomy for DIE, because to unclear definitions and lack of standardization. We therefore believe it is necessary to propose a standardization of the definition of parametrectomy performed during procedures for DIE, to allow a clear comparison in the future between scientific works on surgical treatment of DIE, as already widely accepted in gynaecologic oncology with the classification of radical hysterectomy of Querleu-Morrow. In particular we believe that the parametrectomy for DIE must be described based on its anatomical extension and focused on the concepts of nerve sparing dissection, and vascular structures preservation, to reduce the risk of complications due to ischemia (i.e. ureter fistula). Rationale A standardized description of the procedure (parametrectomy) will allow the comparison between the different techniques in terms of functionality preservation of the pelvic sympathetic and parasympathetic neural pathway. Therefore, the availability of a clear classification able to define parametria involvement during surgery would be clinically relevant, as they would allow to optimize counselling (risk of neurological consequences) and surgery planning. Type of the study Multicentric prospective observational study. Primary objective To determinate the incidence of bladder functional impairment, after surgery for DIE involved the parametria. Secondary objectives To classify the parametrectomy into a clear system of classification, based on anatomical landmark, and evaluate intra/postoperative complication to each classes of proposed parametrectomy. Sample size The sample size has been calculated on the basis of the primary objective; in order to detect a proportion of bladder functional impairment of 30%, with a confidence level of 95% and a margin of error of 9%, a sample of N=100 patients is required. Inclusion criteria - Patient scheduled for surgery for DIE - Confirmation of DIE needed of parametrectomy at laparoscopic surgery Exclusion criteria - Patients younger than 18 years and older than 50 years at time of operation - Refusal to answer the questionnaires - Absence of sexual activity - Diagnosis of multiple sclerosis - Pre-operative urodynamic diagnosis of neurogenic bladder dysfunction Statistical analysis The sample will be described in its clinical and demographic characteristics using descriptive statistics techniques. Qualitative variables will be summarized as frequencies and percentages. Quantitative variables will be presented as mean (std.dev). Normality of data will be checked with Kolmogorov-Smirnov test. The primary objective will be achieved calculating the incidence of bladder functional impairment after surgery. The secondary objective will be achieved using descriptive statistics techniques already described.

NCT ID: NCT04664660 Recruiting - Endometriosis Clinical Trials

Endometriosis and Obstetric Outcomes

Start date: March 10, 2020
Phase:
Study type: Observational

The purpose of this study is to assess if endometriosis can be considered a risk factor for adverse obstetric and delivery outcomes

NCT ID: NCT04610710 Recruiting - Infertility, Female Clinical Trials

Impact of Operation on Fertility for Women With Severe Endometriosis

EFFORT
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

The EFFORT study compares the impact on fertility of operation or fertility treatment (IVF, in vitro fertilization) in a multicenter randomized controlled trial. The study population consists of women with colorectal deep infiltrating endometriosis and a pregnancy intention. These women will be randomized to either of the two treatment groups: Group A = Operation or Group B = fertility treatment (IVF). Group A will be further divided postoperatively into spontaneous conception or IVF depending on the Endometriosis Fertility Index score.

NCT ID: NCT04598698 Recruiting - Endometriosis Clinical Trials

The EMPOWER Study: Endometriosis Diagnosis Using microRNA

EMPOWER
Start date: November 2, 2020
Phase:
Study type: Observational

Endometriosis is a complex, heterogeneous disease that may present inconsistently across women. Using disease-specific biomarkers and advanced biostatistics, DotLab is developing a biomarker test to confirm the presence of endometriosis.This is a multi-center, prospective, observational, minimal risk study in women undergoing laparoscopy, laparotomy or other pelvic surgical procedure for endometriosis, infertility or another benign gynecological indication. Participants will undergo 2 study visits for collection of blood and saliva and completion of study questionnaires.

NCT ID: NCT04567771 Recruiting - Endometriosis Clinical Trials

Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer

Start date: December 4, 2020
Phase: N/A
Study type: Interventional

This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors. Using quality of life questionnaires and adverse event assessments may help doctors learn whether proton radiation therapy is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy in patients with endometrial or cervical cancer.

NCT ID: NCT04554693 Recruiting - Endometriosis Clinical Trials

The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery

Start date: October 19, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine a difference in participant reported pain after endometriosis surgery in participants given oral metronidazole versus placebo.

NCT ID: NCT04527003 Recruiting - Endometriosis Clinical Trials

Cannabidiol and Management of Endometriosis Pain

Start date: December 4, 2020
Phase: Phase 3
Study type: Interventional

The investigators are looking to conduct a study looking at the effects of cannabidiol (CBD) in patients with endometriosis. It is believed that CBD will improve both pain and quality of life. The study will last a total of 12 weeks and involve several onsite visits in addition to daily pain assessments.

NCT ID: NCT04481321 Recruiting - Endometriosis Clinical Trials

Clinical and Molecular Study of Endometriosis and Adenomyosis

ENDOCHAP
Start date: May 2006
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to determine whether endometriosis and adenomyosis are progressive diseases, in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions size, and recurrences. We also aimed to address molecular questions on immune dialogues between ectopic lesions and the eutopic endometrium, auto-immunity in endometriosis and adenomyosis and the role of the microbiota in their respective pathophysiologies.