Impact of Different Saline Pressures During Hysteroscopy on Visibility, Feasibility and Patients' Discomfort

NCT06620978 | Not Yet Recruiting DMC

• 1 other identifier: 134-24-ASF
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hysteroscopy is a minimally invasive diagnostic and therapeutic procedure for various intrauterine conditions. It is performed with an optic device while entering liquid media to the uterus to allow visualization. Diagnostic procedures are often performed without anaesthesia (in the office setting) and operative procedures are performed either under general anaesthesia or without anaesthesia (in the office setting). It depends on the patients' characteristics and preferences, and surgical indications. 80%-100% of operative procedure without anesthesia can be successfully completed. The main reasons for inability to successfully complete operative hysteroscopy without anesthesia are patients' discomfort and limited visibility of the uterine cavity. In the current study, the investigators will compare the use of two different pressure setting of the liquid media during operative hysteroscopy without anesthesia, with the aim of investigating the successful completion of the procedure and patient's discomfort, with the aim of determining the optimal pressure setting.

Conditions

Endometrial Polyps; Retained Products of Conception; Lysis of Intrauterine Adhesions; Removal of Retained Intrauterine Device

Outcome Measures

Primary Outcomes (2)

• To compare the rate of successful completion rate of operative hysteroscopy without anesthesia using low pressure (100 mmHg) versus high pressure (150 mmHg) normal saline for distention medium.

  The feasibility and success of the procedure would be evaluated by the surgeon using a questionnaire.

  The questionnaire will be filled immediately after the procedure.

• Feasibility and uterine cavity visibility of operative hysteroscopy without anesthesia using low versus high pressure normal saline for distention medium.

  Feasibility and uterine cavity visibility of operative hysteroscopy without anesthesia using low pressure (100 mmHg) versus high pressure (150 mmHg) normal saline for distention medium. The feasibility of the procedure would be evaluated by the surgeon using a questionnaire.

  The questionnaire will be filled immediately after the procedure.

Secondary Outcomes (1)

• Patients' discomfort during operative hysteroscopy without anesthesia using low versus high pressure normal saline for distention medium.

  Visual Analog Scale (VAS) will be filled immediately after the procedure.

Study Arms (2)

Low pressure

ACTIVE COMPARATOR

Low pressure (100 mmHg) Saline medium during hysteroscopy.

Procedure: Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure..

High pressure

ACTIVE COMPARATOR

High pressure (150 mmHg) Saline medium during hysteroscopy.

Procedure: High pressure: Operative hysteroscopy without anesthesia with normal Saline medium in High pressure.

Interventions

Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure.. PROCEDURE

Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure.. Operative hysteroscopy without anesthesia using normal Saline as medium with different pressure according to the arm allocated. The procedure is done for endometrial polyp removal, retained products of conception removal, intrauterine adhesyolisis and intrauterine device removal.

Low pressure

High pressure: Operative hysteroscopy without anesthesia with normal Saline medium in High pressure. PROCEDURE

High pressure: Operative hysteroscopy without anesthesia with normal Saline medium at high pressure.

High pressure

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women age \>18 years
• Willing to undergo operative hysteroscopy without anesthesia for
• The following intrauterine findings:
• A. Endometrial polyps \<1.5 cm B. Retained products of conception \<1.5 cm C. Lysis of intrauterine adhesions D. Removal of retained intrauterine device

You may not qualify if:

• Contraindication for hysteroscopy including: suspected pregnancy, heavy concomitant vaginal bleeding, known genital tract malignancy, suspected concurrent genital tract infection.
• Unable to sign informed consent
• Unable to read/write Hebrew

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Related Publications (3)

• Shahid A, Pathak M, Gulumser C, Parker S, Palmer E, Saridogan E. Optimum uterine filling pressure for outpatient diagnostic hysteroscopy: a double-blind, randomized controlled trial. Reprod Biomed Online. 2014 Jan;28(1):86-91. doi: 10.1016/j.rbmo.2013.07.018. Epub 2013 Sep 14.

  PMID: 24262433 BACKGROUND

• De Silva PM, Stevenson H, Smith PP, Justin Clark T. A Systematic Review of the Effect of Type, Pressure, and Temperature of the Distension Medium on Pain During Office Hysteroscopy. J Minim Invasive Gynecol. 2021 Jun;28(6):1148-1159.e2. doi: 10.1016/j.jmig.2021.01.003. Epub 2021 Jan 11.

  PMID: 33444792 BACKGROUND

• Salazar CA, Isaacson KB. Office Operative Hysteroscopy: An Update. J Minim Invasive Gynecol. 2018 Feb;25(2):199-208. doi: 10.1016/j.jmig.2017.08.009. Epub 2017 Aug 10.

  PMID: 28803811 BACKGROUND

Related Links

• Enter the website. Type \"Hysteroscopy managing fluid and gas distending media\".

MeSH Terms

Interventions

Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Neta Eisenberg Kogan

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neta Eisenberg Kogan, Doctor (MD)

CONTACT

+972542573878; netae@shamir.gov.il

Maayan Gal Kochav, Doctor (MD)

CONTACT

+972508683898; maayangk24@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician in the gynecology endoscopic unit

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: November 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: data will be available once study is completed for an unlimited period
• Access Criteria: Will be shared via appropriated publications for public use