The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy

NCT ID: NCT04436354

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-04-16

Brief Summary

The present study revealed that the TL position is supposed to be more efficient not only for lowering pain score but also reducing the procedural time. Also, performing hysteroscopy in this position may be easier for doctors than in the lithotomy position.

Detailed Description

VOH is a widely used diagnostic method and seems to be getting more into outpatient clinics. Despite its huge contribution to clinical practice, pain during the procedure is an important limiting factor. We aimed to investigate the effect of the trendelenburg lithotomy position to the pain and procedural time.However, there is a scarcity of research on this subject. Therefore, the rationale of the study was to enlighten the gap in the literature regarding the pain score and procedural time during VOH for diagnostic purposes in TL position. In order to gain scientific evidence, a randomized controlled trial was conducted to compare pain score and duration of procedure between the standard lithotomy position and TL position. Also, the convenience for the physician performing the procedure was assessed. To the best of our knowledge, this is the first study in the literature investigating the effect of the position of the patient during the procedure on both time, pain, and the convenience for the physician simultaneously.

Conditions

Uterine Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

vaginoscopic office hysteroscopy in the trendelenburg position

Group Type: EXPERIMENTAL

vaginoscopic office hysteroscopy

Intervention Type: PROCEDURE

comparison of procedural time and pain scores of patients in different gynecologycal positions

vaginoscopic office hysteroscopy in lithotomy position

Group Type: EXPERIMENTAL

vaginoscopic office hysteroscopy

Intervention Type: PROCEDURE

comparison of procedural time and pain scores of patients in different gynecologycal positions

Interventions

vaginoscopic office hysteroscopy

comparison of procedural time and pain scores of patients in different gynecologycal positions

Intervention Type: PROCEDURE

Other Intervention Names

positions

Eligibility Criteria

Inclusion Criteria

• uterine disorders
• abnormal uterine bleeding
• infertility

Exclusion Criteria

• pregnancy
• cervical disorders
• pelvic infections

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fatma ketenci gencer

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Saglik Bilimleri University Gaziosmanpasa Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GaziosmanpasaTREHa

Identifier Type: -

Identifier Source: org_study_id