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Genital Diseases, Female clinical trials

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NCT ID: NCT04258449 Recruiting - Clinical trials for Women With Suspected or Confirmed Gynecological Disease

DOvEEgene Fleur: New Uterine Sampling Tool

Start date: December 11, 2020
Phase:
Study type: Observational

This study is related to a previous study from the same group which started in 2014 (NTC02288676, McGill REB A08-M79-13B, MUHC REB 2020-5945) to develop a clinically implementable screening test -DovEEgene: developing and validating a novel molecular test for the early diagnosis of cancer of the endometrium, tubes and ovaries. This study is designed to identify endometrial, tubal and ovarian cancer very early based on identifying cancer-specific mutations (cancer DNA) in a pap sample taken from inside the uterus. The results are particularly encouraging given that control group is challenging with high background mutational burden from benign tumours, endometriosis, germ-line mutations etc. To date, all the intrauterine samples were obtained using the commercially available TAO brush™ which is designed to take an endometrial sample. However, when patient tolerability was assessed using a numerical pain scale (NPS) ranging from 0 (no pain) to 10 (severe pain), patients rated the sampling using the TAO brush™ at 3.5 versus 0 for a cervical pap sample. These results were not surprising as the TAO brush™ was designed for dislodging strips of endometrial tissue to use for histopathologic examination. With respect to the investigators objective, which is to collect cancer cells that have exfoliated to the uterus, a sampler that collects these exfoliated cells with as little disturbance as possible to the underlying endometrium is preferred. In this sub-study, the investigators aim to evaluate a new endometrial sampling tool, the DOvEEgene Fleur, which is believe to be superior to the current TAO brush™ in terms of cancer detection, ease of use and patient tolerability. The sampler has been designed using materials/components found in the TAO brush™ and other approved medical devices.

NCT ID: NCT04221308 Completed - Inflammation Clinical Trials

Inflammatory Markers in Natural Orifice Hysterectomies

Start date: January 1, 2018
Phase:
Study type: Observational

The authors aimed to detect inflammatory marker changes in two natural orifice hysterectomies: single-port laparoscopic hysterectomy (SLH) and vaginal hysterectomy (VH). Between 2018 and 2019, data obtained from patients in the SLH and VH groups were reviewed retrospectively. The preoperative and postoperative hematocrit (HCT), hemoglobin (HB), white blood cell (WBC), platelet (PLR), and neutrophil-lymphocyte (NLR) ratios and values were compared as well as the demographic characteristics of the patients.

NCT ID: NCT04216979 Active, not recruiting - Gynecologic Disease Clinical Trials

Palmer's Point Versus The Umbilicus As Routine Primary Entry Site In Gynecologic Laparoscopy

Start date: December 15, 2019
Phase: N/A
Study type: Interventional

we will compare the classic method of using the umbilicus as the primary entry site in gynecological laparoscopy with Palmar's point

NCT ID: NCT04184765 Completed - Inflammation Clinical Trials

Inflammatory Markers in Hysterectomies

Start date: January 1, 2018
Phase:
Study type: Observational

This retrospective study was conducted in the obstetrics and gynecology clinic at Derince Training and Research Hospital. The study group was identified as patients who underwent hysterectomy between 2018 and 2019. Our hospital is a 50-bed tertiary reference center where approximately 3,500 births per year occur, and about 500 gynecological-oncological surgeries are performed annually. The records of patients who underwent LH and AH were reviewed retrospectively. Preoperative and postoperative blood values in the first 24 hours after surgery were compared: hematocrit (HCT), hemoglobin (HB), WBC, PLR, and NLR values were compared as well as the demographic characteristics of the patients who underwent these procedures. In addition, to evaluate the effect of ovaries on the inflammatory markers, the patients were divided into two groups: oophorectomy and non-oophorectomy. In our clinic, the decision to perform a hysterectomy is made by the weekly gynecology council. The type of surgery is determined according to the clinical condition of the patient, the gynecological examination, and the patient's request. In general, open surgery is preferred in patients with giant fibroids, many previous surgeries, and immobile uteri. Conditions such as dysfunctional uterine bleeding, cervical intraepithelial neoplasms, and uterine descensus indicate the need for LH. In cases where there is no clinical suspicion, oophorectomy is performed according to the patients' wishes. In benign cases, the preferred type of hysterectomy is type 1 extra facial hysterectomy. In LH, the procedure is performed as follows: The uterine manipulator is inserted vaginally. First, a Veress needle and then a trocar are entered through the umbilicus. The abdomen is insufflated with carbon dioxide, and the appropriate number of ports is placed. Uterine ligaments and vessels are cut by using bipolar energy. The uterus is removed through the vagina, and the vaginal cuff is sutured laparoscopically. Patients with chronic diseases (e.g., hypertension, diabetes mellitus, and rheumatologic, nephrological, and hematological diseases), the presence of active infection, corticosteroid use, acetylsalicylic acid, and anticoagulant use were not included in the study. Bladder and bowel injuries, blood transfusion requirements, wound infection and hematoma, postoperative respiratory system complications (e.g., atelectasis) were evaluated as surgical complications.

NCT ID: NCT04171297 Active, not recruiting - Surgery Clinical Trials

Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery

IDEA1
Start date: September 25, 2019
Phase:
Study type: Observational

An international multicenter observation study to evaluate the diagnostic accuracy and predictive value of ultrasound using the IDEA terminology in the detection of deep endometriosis in women scheduled for surgery.

NCT ID: NCT04064216 Completed - Quality of Life Clinical Trials

Comparison of Cosmesis, Patient Satisfaction and Quality of Life in Patients Undergoing Laparoscopic Surgery

Start date: July 16, 2019
Phase:
Study type: Observational [Patient Registry]

To compare robot assisted versus conventional laparoscopic surgery performed for bening gynecologic disorders regarding cosmesis, patient satisfaction and quality of life

NCT ID: NCT04061967 Recruiting - Cervical Cancer Clinical Trials

SMS-based Summons in Cervical Screening

Start date: August 19, 2019
Phase: N/A
Study type: Interventional

Prevention of cervical cancer with cervical screening is one of the most successful screening activities in medicine. In Sweden, screening was implemented in the 1960s and has since prevented tens of thousands of women from having cervical cancer. Individual invitations to screening result in increased attendance therefore evaluating strategies for reaching women through invitations is particularly valuable. Women who regularly attend screening following an invitation reduce their risk of cervical cancer by as much as 90%. Of the women who are diagnosed with cervical cancer (about 550 women per year in Sweden), as many as 38% did not participate in the screening. Invitations for screening are sent to the entire population in Sweden aged 23-70. The current coverage of screening is 82.9%, which represents the proportion of women ages 23-70 who attend according to recommendations. In addition, many women are sporadic attenders who reduce their risk for cancer somewhat. The highest cancer risk is seen among those women who have never participated as well as women who have had a history of precancerous lesions or HPV infection but have not been followed-up. Cervical cancer is the first form of cancer for which there are approved molecular screening tests (HPV test). Unlike the older screening method (cytology), self-collected samples can be analyzed for HPV (the analysis method is so sensitive that it does not matter if the sample is not optimally taken). Invitations and reminders about cervical screening are sent by letter to the woman's home address (about 3 million letters per year in Sweden). This strategy results in a waste of resources and has a negative environmental impact. Regarding reminders, we have seen in previous research that the effect is not optimal. When sending a physical reminder letter to women who have not participated in more than 10 years (current routine), only 2% of the women invited came for sampling. Reminders with SMS are now standard for many businesses in society, such as car testing or dental appointments. It is inexpensive, saves the environment and there are studies that suggest it is more effective than sending physical letters. In this study, we intend to investigate whether SMS reminders, electronic letters, and physical letters for screening lead to increased participation and thus to a higher proportion of detected, treatable precursors of cervical cancer compared to before.

NCT ID: NCT04048356 Completed - Clinical trials for Urinary Incontinence

Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures

CLNUP
Start date: July 15, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.

NCT ID: NCT04042129 Completed - Gynecologic Disease Clinical Trials

Urological Complications and Management After Gynecological Operations

Start date: January 2016
Phase:
Study type: Observational

OBJECTIVE: In the study, investigators aimed to evaluate the urological complications of gynecologic operations in a tertiary academic center and to evaluate the treatment methods of these complications. METHODS: The files of all patients who underwent gynecological surgery between January 2016 and January 2019 were retrospectively reviewed. The age of patients with urological complications, American Anesthesia Society score, menopausal status, body mass index (BMI), preoperative hemoglobin level, postoperative hemoglobin level and hospitalization duration and number of previous surgeries were recorded. In addition, the patients with urological complications were evaluated in terms of the indications for surgery, type of surgery, type of urological complication and the way of treatment of the complication.

NCT ID: NCT03988348 Recruiting - Gynecologic Disease Clinical Trials

Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion

Start date: August 4, 2019
Phase: N/A
Study type: Interventional

Laparoscopic surgery is now a well-established alternative to open surgery for many gynecological disorders owing to its faster wound healing, shorter hospital stay, less postoperative pain, and better cosmetic results. Postoperative scar cosmoses is a critical issue for women, especially for young women. These scars may have negative impacts, such as psychological consequences. The symptoms associated with the wound, such as pain, tenderness, and itching, can be induced by the scars