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The purpose of the study is to investigate the advantages and disadvantages of bladder filling during hysteroscopy procedure.
Women who should have diagnostic hysteroscopy procedure will be randomly allocated into two groups. In the first group hysteroscopy will be performed with a filled bladder and in the second group procedure will be performed with an empty bladder. The women will be assigned into groups randomly. The duration of the procedure, feasibility of the procedure and tolerability of procedure will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Bladder | Experimental | Hysteroscopy conducted under full bladder. |
|
| Empty Bladder | Experimental | Hysteroscopy conducted under empty bladder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hysteroscopy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Cervical Entry | Ease of cervical entry which will be assessed by Likert scale.The outcome measures in this study were the ease of cervical entry (judged by the individual surgeons using a 5-point Likert scale: very difficult= 1, difficult= 2, fair = 3, easy= 4, and very easy = 5. | 2 months |
| Pain Scoring(VAS) | Pain scoring was made by 10 cm visual analog scale. pain score (recorded by the patient on a 10 -point visual analog scale (VAS) which means pain increases with increasing number | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Acceptability and Pain Scoring | Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale. | two months |
| Procedure Duration | Procedural time which will be measured in minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cem Celik, Assist Prof | Namik Kemal University Faculty of Medicine Department of Obstetrics and Gynecology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Namık Kemal University Faculty of Medicine Department of Obstetric and Gynecology | Tekirdağ | 59100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18439502 | Background | Kabli N, Tulandi T. A randomized trial of outpatient hysteroscopy with and without intrauterine anesthesia. J Minim Invasive Gynecol. 2008 May-Jun;15(3):308-10. doi: 10.1016/j.jmig.2008.01.013. Epub 2008 Mar 20. | |
| 22387163 | Background | Carta G, Palermo P, Marinangeli F, Piroli A, Necozione S, De Lellis V, Patacchiola F. Waiting time and pain during office hysteroscopy. J Minim Invasive Gynecol. 2012 May-Jun;19(3):360-4. doi: 10.1016/j.jmig.2012.01.017. Epub 2012 Mar 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Empty Bladder | Hysteroscopy conducted under empty bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy |
| FG001 | Full Bladder | Hysteroscopy conducted under full bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Empty Bladder | Hysteroscopy conducted under empty bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy |
| BG001 | Full Bladder | Hysteroscopy conducted under full bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ease of Cervical Entry | Ease of cervical entry which will be assessed by Likert scale.The outcome measures in this study were the ease of cervical entry (judged by the individual surgeons using a 5-point Likert scale: very difficult= 1, difficult= 2, fair = 3, easy= 4, and very easy = 5. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Empty Bladder | Hysteroscopy conducted under empty bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy |
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difficulties in introduction of hysteroscopy
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| cem celik | namik kemal university | 905324205365 | cemcel@yahoo.com |
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| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D015907 | Hysteroscopy |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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| two months |
| 10648742 | Background | De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2. |
| 15200787 | Background | Pansky M, Feingold M, Bahar R, Neeman O, Asiag O, Herman A, Sagiv R. Improved patient compliance using pediatric cystoscope during office hysteroscopy. J Am Assoc Gynecol Laparosc. 2004 May;11(2):262-4. doi: 10.1016/s1074-3804(05)60211-3. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Patient Acceptability and Pain Scoring | Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale. | Not Posted | two months |
| Secondary | Procedure Duration | Procedural time which will be measured in minutes | Not Posted | two months |
| Primary | Pain Scoring(VAS) | Pain scoring was made by 10 cm visual analog scale. pain score (recorded by the patient on a 10 -point visual analog scale (VAS) which means pain increases with increasing number | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Full Bladder | Hysteroscopy conducted under full bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy | 0 | 47 | 0 | 47 |
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |