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

NCT ID: NCT02691715

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Endometrial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Endometrial saline plus curettage

5 cc saline infused to the endometrial cavity and aspirated. Then routine endometrial curettage performed for same participant.

Group Type EXPERIMENTAL

Endometrial saline plus curettage

Intervention Type PROCEDURE

Endometrial curettage

Only routine endometrial curettage performed

Group Type ACTIVE_COMPARATOR

Endometrial curettage

Intervention Type PROCEDURE

Interventions

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Endometrial saline plus curettage

Intervention Type PROCEDURE

Endometrial curettage

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Abnormal uterine bleeding

Exclusion Criteria

* Involuntary, under 35 years old,
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Baki Senturk

Pirincipal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mehmet Baki Şentürk, MD

Role: CONTACT

+90 541 773 71 76

Çetin Kılıççı, MD

Role: CONTACT

+90 505 644 94 85

References

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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.

Reference Type RESULT
PMID: 19305334 (View on PubMed)

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.

Reference Type RESULT
PMID: 25568988 (View on PubMed)

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.

Reference Type RESULT
PMID: 19509571 (View on PubMed)

Other Identifiers

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168

Identifier Type: -

Identifier Source: org_study_id

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