Tenaculum in Endometrial Sampling Procedure

NCT01506778 | Completed

• 1 other identifier: CukurovaU
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a single tooth tenaculum to the cervix for steady the cervix, straighten the cervicouterine angle and provide countertraction. However, grasping the cervix with a tenaculum can be a painful experience for the patient.A randomized controlled trial was conducted to evaluate using of tenaculum on pain perception of the patients and the procedure performance of the surgeons in endometrial sampling procedure(ESP) with pipelle.

Conditions

Endometrium; Biopsy

Keywords

Endometrial Sampling Procedure; Likert Scala; Pipelle; Tenaculum; Visual Analog Pain Scala

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scala for patient's pain perception

  VAS performed four times each patient.

  5 second

Secondary Outcomes (2)

• Likert scala for procedure performance

  5 second

• Success rate as adequate sampling of endometrial tissue for histopathologic diagnosis.

  5-10 day

Study Arms (2)

Group 1(With Tenaculum)

ACTIVE COMPARATOR

This group consisted of the patients whose had been applied tenaculum at cervix during the endometrial sampling procedure

Device: Tenaculum

Group 2 (Without Tenaculum)

NO INTERVENTION

This group consisted of the patients whose had been not applied tenaculum during the endometrial sampling procedure.

Interventions

Tenaculum DEVICE

Single tooth tenaculum are use to the cervix for steady the cervix, straighten the cervicouterine angle and provide countertraction. Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a tenaculum.

Group 1(With Tenaculum)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• The women has required endometrial sampling procedure in gynecology outpatients clinic.
• Who are capable understand the spoken words and describe the pain.

You may not qualify if:

• Stenotic cervical canal
• They had acute cervicitis
• Intense anxiety
• Need for coincident endocervical curettage
• Need for general anesthesia or local anesthetics
• The use of analgesic drug pre-procedure
• Known history of malignancy
• Uterine anomalies or leiomyomas that distort the cervical canal and cavity
• A history of failed office endometrial sampling
• Positive β-HCG test.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University Faculty of Medicine

Adana, 01330, Turkey (Türkiye)

Location

Study Officials

• Ahmet Baris Guzel, Assist Prof Dr.

  Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Aybala Kubat, MD

  Şahinbey Goverment Hospital

  PRINCIPAL INVESTIGATOR

• Ghanim Khatib, MD

  Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Fatma Tuncay Ozgunen, Prof Dr.

  Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Ibrahim Ferhat Urunsak, Assist Prof Dr.

  Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Umran Kucukgoz Gulec, Assist Prof Dr.

  Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 10, 2012
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 10, 2012

Record last verified: 2012-01

Locations

TU (1)