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Neoplasms, Connective Tissue

Connective Tissue Diseases

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Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Group of patients in which office hysteroscopy will be performed prior to endometrial biopsy

Group of patients in which endometrial biopsy will be performed prior to office hysteroscopy

Office hysteroscopy is a procedure performed in the office in which a flexible hysteroscope is inserted into the uterine cavity. The patient is positioned in a dorsal lithotomy position and teh cervix is visualized with a speculum. Normal saline is used to distend the cavity, and the hysteroscope is used to visualize any abnormalities within the cavity.

Office hysteroscopy

An endometrial biopsy is a procedure in which a pipelle instrument is inserted into the uterine cavity and suction from the pipelle is used to obtain endometrial tissue. This is performed with the patient in the dorsal lithotomy position and a speculum is used to visualize the cervix.

Endometrial biopsy

Anthony Imudia, MD

This study will look at the optimal order in which to perform concurrent office hysteroscopy and endometrial biopsy in female patients who present for evaluation of abnormal uterine bleeding at a fibroid and endometriosis treatment center.

This will be a prospective single blinded randomized control trial to determine whether the order of performance of office hysteroscopy (OH) and endometrial biopsy (EMB) during the same office evaluation for abnormal uterine bleeding affects the patient's pain perception. We also intend to investigate whether the order of the procedures affects the adequacy of the endometrial sample, duration of the procedure, and optimal visualization of the uterine cavity. We hypothesize that performing EMB prior to OH will result in higher patient pain scores.

Included patients will be all consecutive female patients ages 18-70 presenting to the University of South Florida Center for Endometriosis and Fibroid Treatment (CFERT) for evaluation of abnormal uterine bleeding or uterine fibroids.

Patients will be randomly assigned to have either OH followed by EMB or EMB followed by OH as part of their clinical assessment of AUB/uterine fibroid based on clinical indication. The patients will be informed about the two indicated procedures by their clinical provider but will be blinded to the order of performance. The healthcare provider/investigator will be aware of the order in which the procedures are assigned and to be performed. Patients will be consented to participate in the study prior to the procedure by the study team on the day the indicated procedures are scheduled in CFERT. The healthcare provider performing the procedure will open an unlabeled envelope, within which there will be a piece of paper indicating which procedure is to be performed first. This will then be recorded in the study log. The study log will include enrolled patients, assigned study number which will range from 001 to the minimum number of patients required for the study as indicated by sample size calculation.

At the end of the procedures, patient will be asked to describe their pain perception based on Visual analogue scale (VAS) from 0-10. The adequacy of the endometrial sample will be determined from the pathology report. The duration of the entire procedures (min) will be timed using a stopwatch from the time of insertion of the hysteroscope/Pipelle catheter in the external cervical canal to removal of the instruments. A panoramic picture of the endometrial cavity will be taken and will be given to a blinded independent reviewer to determine the adequacy of visualization based on 3 point scoring system (fair, good and excellent). Fair visualization will be defined as no tubal ostia visualized; good will be defined as both tubal ostia identified but only able to visualize 180 degrees of panorama; excellent visualization will be defined as visualizing bilateral tubal ostia and having a clear image of the uterine cavity in 360 degrees of panorama.

Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy

Office Based Evaluation of Patients Presenting With Abnormal Uterine Bleeding and/or Uterine Fibroids With Concurrent Office Hysteroscopy and Endometrial Biopsy; Does the Order Matter?

After the procedures are performed, the patient will be asked to describe their pain perception based on Visual analogue scale (VAS) from 0-10

The adequacy of the endometrial sample will be determined from the pathology report.

The duration of the entire procedures (min) will be timed using a stopwatch from the time of insertion of the hysteroscope/Pipelle catheter in the external cervical canal to removal of the instruments.

A panoramic picture of the endometrial cavity will be taken and will be given to a blinded independent reviewer to determine the adequacy of visualization based on 3 point scoring system (fair, good and excellent). Fair visualization will be defined as no tubal ostia visualized; good will be defined as both tubal ostia identified but only able to visualize 180 degrees of panorama; excellent visualization will be defined as visualizing bilateral tubal ostia and having a clear image of the uterine cavity in 360 degrees of panorama.

University of South Florida

Endometrial Neoplasms

100 women with postmenopausal bleeding undergoing 2D greyscale vaginal ultrasound and 3D Endometrial power Doppler and the features were classified using six different vascular patterns described by IETA group including the following patterns; single dominant vessel without branching, with branching, multiple vessels with focal origin, with multifocal origin at the myometrium-endometrium junction, scattered vessels or circular flow (Kucur et al., 2013 ).

All patients then had Office hysteroscopy carried out in the outpatient clinic using vaginoscopic approach (Cooper et al., 2010). With endometrial samples from lesions or from the cavity for histopathological analysis.

To assess the endometrial thickness and echogenicity (whether the endometrium is uniform or non-uniform).

2D grey scale vaginal ultrasound

To assess the endometrium using the IETA group criteria.

3D power Doppler vaginal ultrasound

using the vaginoscopic approach to assess the uterine cavity and take sample.

100 patients with postmenopausal bleeding were assessed with 2D vaginal ultrasound and 3D power Doppler ultrasound using the international endometrial tumor analysis group and office hysteroscopy with taking samples for histopathological analysis.

The aim was to compare the efficiency of the upper mentioned interventions in diagnosing the cause of postmenopausal bleeding.

Sample from the uterine endometrium for histopathological analysis

Office Hysteroscopy and 3D Power Doppler Vaginal Ultrasound in Assessment of Postmenopausal Bleeding

The Role of Office Hysteroscopy and Endometrial Power Doppler Using the International Endometrial Tumor Analysis Group Classification in the Evaluation of Postmenopausal Bleeding

Efficacy of 3D power Doppler ultrasound with the IETA group criteria in diagnosing the cause of postmenopausal bleeding

Cairo University

Rare Diseases

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Cervical Intraepithelial Neoplasia

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Antineoplastic Agents

Micronutrients

Vitamins

Ethanol

Acetic Acid

Retinol acetate

Iodine

Cadexomer iodine

Cervical Pap smears will be obtained using the long tip of an Ayre's spatula that will be placed in the endocervical canal with the proximal bulge resting on the ectocervix. The spatula will be carefully rotated around the cervix so that a representative sample of the whole cervix will be obtained. An additional endocervical sample will be obtained by placing a cytobrush or by the other end of the Ayer's spatula in the endocervical canal and gently rotated through 360 degrees as previously described. The samples will be then immediately plated on a slide, fixed by immersing the slide in 95% ethyl alcohol fixative for 15 to 20 minutes and stained by modified Papanicolaou stain using a hand staining procedure

3- Cervical Pap smears

0.9% saline technique to assess the cervical lesion and vasculature of the cervix, 5% acetic acid technique to determine acetowhite-positive areas. Schiller's iodine technique to visualize high glycogen containing cells. Endocervical canal assessment using (Bossman forceps or endocervical speculum or counter pressure with Q stick).

e- Biopsy using the punch biopsy forceps. Biopsy will be obtained from every abnormal colposcopic examination

Colposcopic examination

0.9% saline technique to assess the cervical lesion and vasculature of the cervix. 5% acetic acid technique to determine acetowhite-positive areas. Schiller's iodine technique to visualize high glycogen containing cells. Endocervical canal assessment. Endometrial cavity evaluation whenever possible. Biopsy. Biopsy will be obtained from every abnormal hysteroscopic examination.

Mohammed K ALi, MD

Endocervix (cervical canal) is the cavity of the cervix and connects the external os with the internal os. It is fusiform in shape and has posterior and anterior oblique longitudinal ridges, the plicae palmatae. These are not exactly apposed but inter-lock like a zipper so that the canal is kept closed.

The original squamous epithelium is clearly identified as a smooth, usually featureless covering of the cervix; its uniform pink color contrasts with the redness of the original columnar epithelium. It joins the latter at the original squamocolumnar junction.

Many clinicians encounter cervical lesions that may or may not be associated with cytologic abnormalities. Such abnormalities as ectropion, Nabothian cysts, and small cervical polyps are quite benign and need not generate concern for patient or clinician, whereas others, including those associated with a history of exposure to diethylstilbestrol, cervical inflammation, abnormal cervical cytology, and postcoital bleeding, should prompt additional evaluation. Further, in some patients, the cervix may be difficult to visualize. Several useful clinical suggestions for the optimal examination of the cervix are presented.

Diagnosis of Cervical Lesions in Women With Unhealthy Looking Cervix

Office Hysteroscopy Versus Stationary Coloposcopy for Diagnosis of Cervical Lesions in Women With Unhealthy Looking Cervix

Assiut University

Lecturer of obstetrics and gynecology

Immune System Diseases

Hypersensitivity

Hyperplasia

Endometrial Hyperplasia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Bone Density Conservation Agents

Tamoxifen

Abnormal Uterine Bleeding (AUB) in Post-Menopause

Ultrasonographic detection of Thickened Endometrium in post-menopause

Ultrasonographic detection of Thickened Endometrium in pre-menopause

Patients who had been treated with Tamoxifen

Patients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Histopathological examination was conducted to confirm the diagnosis.

Office Hysteroscopy

A prospective cohort study at a Tertiary University Hospital. From January to December 2018, we enrolled women with the following criteria: abnormal uterine bleeding in post-menopause, endometrial thickening in pre-or post-menopause; tamoxifen usage. Patients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Senior operators had to foresee histopathological diagnosis using a questionnaire. Histopathological examination was conducted to confirm the diagnosis.

Patient underwent the procedure after the menstrual phase (day 6 to 10) of a spontaneous menstrual cycle. All the procedures were performed by means of a continuous flow small-diameter hysteroscope with oval profile (maximum diameter 5 mm, minimum diameter 3.9 mm) (Bettocchi Office Hysteroscope size 5, Karl Storz GmbH \& Co., Tuttlingen, Germany) fitted with a 30-degree telescope of 2.9 mm gauge, using the vaginoscopic approach, without tenaculum and speculum, and using saline solution as distending medium at 90-100 mmHg pressure generated by a pneumatic cuff and measured by means of a manometer; the biopsies were performed with the "punch" or "grasp" technique using a 5 Fr grasping forceps inserted through the operating channel of the hysteroscope. In case of small intrauterine pathologies, they were easily removed by means of a straight bipolar electrode active by an electrosurgical generator (Versapoint II; Gynecare, Ethicon) used to provide a 50W power for the mildest vapour cutting mode (VC3).

The hysteroscopic diagnosis of hyperplasia was based on one or more of the following findings: (1) focal or diffuse, papillary or polypoid, endometrial thickening, (2) Abnormal vascular patterns; (3) evidence of glandular cysts; (4) abnormal architecture features of glandular outlets (thickening, irregular gland density, dilatation). Although no consensus or RCTs showed agreement in describing objective criteria for EH, several trials agreed on the previous morphologic evaluation. \[8\].

The procedures were taken by three senior gynaecologists (P.D.F, L.C., N.C) whose expertise and skills were equivalent. After every procedure, surgeons were asked to propose a suggestive histological categorization of the clinical diagnosis by means of a questionnaire, in order to standardize the assessment. The questionnaire was made of a progressive number which identified the biopsy and a multiple-choice question. Operators were asked to choose one from the following answers: Benign (including atrophic endometrium, proliferative endometrium, endometrial polyp/s); Endometrial Hyperplasia (simple or complex hyperplasia); Atypical Hyperplasia/Carcinoma (including atypical endometrial hyperplasia and adenocarcinoma) Biopsied histological samples were sent for histopathological analysis. The histopathological examination of all the specimens was performed at the Pathology Unit of University of Campania "Luigi Vanvitelli". Three senior gynecopathologists (INS), with the same skills and expertise, were addressed to evaluate all the biopsies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy	NCT02472184	Uterine Fibroid... Vaginal Bleedin...	Office hysteros... Endometrial bio...	18 Years - 70 Years	University of South Florida
Office Hysteroscopy and 3D Power Doppler Vaginal Ultrasound in Assessment of Postmenopausal Bleeding	NCT02488798	Postmenopausal ...	2D grey scale v... 3D power Dopple... Office hysteros...	47 Years - 64 Years	Cairo University
Diagnosis of Cervical Lesions in Women With Unhealthy Looking Cervix	NCT03150745	Cervical Dyspla...	3- Cervical Pap... Colposcopic exa... Office hysteros...	20 Years - 60 Years	Assiut University
Office Hysteroscopy and 3D Power Doppler Vaginal Ultrasound in Assessment of Postmenopausal Bleeding	NCT02488798	Postmenopausal ...	2D grey scale v... 3D power Dopple... Office hysteros...	47 Years - 64 Years	Cairo University
Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy	NCT02472184	Uterine Fibroid... Vaginal Bleedin...	Office hysteros... Endometrial bio...	18 Years - 70 Years	University of South Florida
Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination	NCT03917147	Endometrial Hyp... Endometrial Neo...	Office Hysteros...	18 Years - 60 Years	University of Campania "Luigi Vanvitelli"

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