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

Not Applicable

Completed

• Conditions: Uterine Diseases
• Interventions: Procedure: vaginoscopic office hysteroscopy

• Registration Number: NCT04436354
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

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.

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-04-16
• Status Verified: 2020-06
• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-18
• Last Update Submitted: 2021-09-19
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 157

Inclusion Criteria

• uterine disorders
• abnormal uterine bleeding
• infertility

Exclusion Criteria

• pregnancy
• cervical disorders
• pelvic infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vaginoscopic office hysteroscopy in lithotomy position	vaginoscopic office hysteroscopy	-
vaginoscopic office hysteroscopy in the trendelenburg position	vaginoscopic office hysteroscopy	-

Primary Outcome Measures

Name	Time	Method
Visual Analog Score for pain	12 months	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
procedural times	12 months	minutes

Secondary Outcome Measures

Name	Time	Method
attitudinal Likert type survey	12 months	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.

Trial Locations

Locations (1)

Saglik Bilimleri University Gaziosmanpasa Training and Research Hospital; 🇹🇷 Istanbul, Turkey