Intrauterine Saline Washing for Detection Endometrial Disease in Patients With Abnormal Uterine Bleeding

Endometrial Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02691715
• Other study ID #: 168
• Status: Recruiting
• Phase: N/A
• First received: January 28, 2016
• Last updated: April 26, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: April 2016
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: Mehmet Baki Sentürk, MD
• Phone: +90 541 773 71 76
• Email: dr.baki77[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• Abnormal uterine bleeding

Exclusion Criteria:

• Involuntary, under 35 years old,

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Endometrial Disease
• Uterine Diseases

Intervention

Procedure:
• Endometrial saline plus curettage

• Endometrial curettage

Locations

Country	Name	City	State
Turkey	Zeynep Kamil Maternity and Pediatric Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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: — View 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):881-7. doi: 10.1097/AOG.0b013e31819b3fc7. — View 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):414-23. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical cytological results according to Bethesda 2003	for endometrial washing sample	1 month	Yes
Primary	Endometrial hyperplasiz classification according to World Health Organization 2013	for endometrial curretage sampling	1 month	Yes

External Links

•   Link
•   Link
•   Link