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

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.

Study Overview

• Status: Completed
• Conditions: Uterine Diseases
• Intervention / Treatment: Procedure: vaginoscopic office hysteroscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34255
    • Saglik Bilimleri University Gaziosmanpasa Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• uterine disorders
• abnormal uterine bleeding
• infertility

Exclusion Criteria:

• pregnancy
• cervical disorders
• pelvic infections

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: vaginoscopic office hysteroscopy in the trendelenburg position	Procedure: vaginoscopic office hysteroscopy; comparison of procedural time and pain scores of patients in different gynecologycal positions; Other Names: positions
EXPERIMENTAL: vaginoscopic office hysteroscopy in lithotomy position	Procedure: vaginoscopic office hysteroscopy; comparison of procedural time and pain scores of patients in different gynecologycal positions; Other Names: positions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Score for pain	The Visual Pain Scale (VPS) was used to evaluate pain levels with 0 represented pain-free, while 10 described the most severe pain (Ekin et al. 2009; Price et al. 1983). Patients were asked to mark the pain expressing point on the VPS immediately after VOH. The severity of pain is determined by the value of the point (cm) marked by the participant	12 months
procedural times	minutes	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
attitudinal Likert type survey	with a 5-point attitudinal Likert type survey; a psychometric scale commonly used to score responses in a questionnaire. The ease or difficulty of the procedure was categorized as 1-very easy, 2-easy, 3-ineffective, 4-difficult, 5-very difficult, and the physician performing the procedure marked the appropriate section for each VOH procedure in the scale.	12 months

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): April 16, 2019

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (ACTUAL): June 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 19, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: lithotomy position; vaginoscopic office hysteroscopy; trendelenburg lithotomy position; visual pain score; procedural time; Likert scale
• Additional Relevant MeSH Terms: Uterine Diseases
• Other Study ID Numbers: GaziosmanpasaTREHa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No