Back to resultsIntrauterine Saline Washing for Detection Endometrial Disease in Patients With Abnormal Uterine Bleeding
Primary Purpose
Endometrial Disease
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Endometrial saline plus curettage
Endometrial curettage
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometrial Disease
Eligibility Criteria
Inclusion Criteria:
- Abnormal uterine bleeding
Exclusion Criteria:
- Involuntary, under 35 years old,
Sites / Locations
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Endometrial saline plus curettage
Endometrial curettage
Arm Description
5 cc saline infused to the endometrial cavity and aspirated. Then routine endometrial curettage performed for same participant.
Only routine endometrial curettage performed
Outcomes
Primary Outcome Measures
Cervical cytological results according to Bethesda 2003
for endometrial washing sample
Endometrial hyperplasiz classification according to World Health Organization 2013
for endometrial curretage sampling
Secondary Outcome Measures
Full Information
NCT ID
NCT02691715
First Posted
January 28, 2016
Last Updated
April 26, 2016
Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02691715
Brief Title
Intrauterine Saline Washing for Detection Endometrial Disease in Patients With Abnormal Uterine Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Investigator will examined the diagnostic effect of the endometrial washing by saline. Because this technique more less painful and easier compared to endometrial curettage. Participants will separate into two groups. In study groups before endometrial curettage 5 cc saline infused to the endometrial cavity then aspirate and put into thin prep to examined. After this procedure routine endometrial curettage will be done. In control group only endometrial curettage will be done. Pathologic results of thin prep and curettage will compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endometrial saline plus curettage
Arm Type
Experimental
Arm Description
5 cc saline infused to the endometrial cavity and aspirated. Then routine endometrial curettage performed for same participant.
Arm Title
Endometrial curettage
Arm Type
Active Comparator
Arm Description
Only routine endometrial curettage performed
Intervention Type
Procedure
Intervention Name(s)
Endometrial saline plus curettage
Intervention Type
Procedure
Intervention Name(s)
Endometrial curettage
Primary Outcome Measure Information:
Title
Cervical cytological results according to Bethesda 2003
Description
for endometrial washing sample
Time Frame
1 month
Title
Endometrial hyperplasiz classification according to World Health Organization 2013
Description
for endometrial curretage sampling
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Abnormal uterine bleeding
Exclusion Criteria:
Involuntary, under 35 years old,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet Baki Şentürk, MD
Phone
+90 541 773 71 76
Email
dr.baki77@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Çetin Kılıççı, MD
Phone
+90 505 644 94 85
Email
cetinkilicci@hotmail.com
Facility Information:
Facility Name
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
City
İstanbul
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
19305334
Citation
Moschos E, Ashfaq R, McIntire DD, Liriano B, Twickler DM. Saline-infusion sonography endometrial sampling compared with endometrial biopsy in diagnosing endometrial pathology. Obstet Gynecol. 2009 Apr;113(4):881-887. doi: 10.1097/AOG.0b013e31819b3fc7.
Results Reference
result
PubMed Identifier
25568988
Citation
Rotenberg O, Renz M, Reimers L, Doulaveris G, Gebb J, Goldberg GL, Dar P. Simultaneous endometrial aspiration and sonohysterography for the evaluation of endometrial pathology in women aged 50 years and older. Obstet Gynecol. 2015 Feb;125(2):414-423. doi: 10.1097/AOG.0000000000000631.
Results Reference
result
PubMed Identifier
19509571
Citation
Bese T, Demirkiran F, Guralp O, Sanioglu C, Arvas M. Transtubal transport of carcinoma cells into the peritoneal cavity after saline infusion via transcervical route in patients with endometrial carcinoma. Int J Gynecol Cancer. 2009 May;19(4):682-5. doi: 10.1111/IGC.0b013e3181a48c7f.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/19305334
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=Simultaneous+Endometrial+Aspiration+and+Sonohysterography+for+the+Evaluation+of+Endometrial+Pathology+in+Women+Aged+50+Years+and+Older
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=Transtubal+Transport+of+Carcinoma+Cells+Into+the+Peritoneal+Cavity+After+Saline+Infusion+via+Transcervical+Route+in+Patients+With+Endometrial+Carcinoma
Description
Related Info
Learn more about this trial
Intrauterine Saline Washing for Detection Endometrial Disease in Patients With Abnormal Uterine Bleeding
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