Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy

Sponsor
Ege University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05973045
Collaborator
(none)
244
2
25

Study Details

Study Description

Brief Summary

Minimally invasive applications are seen as the gold standard in today's gynecology practice and are frequently preferred by both patients and physicians. Less pain, shorter hospital stays, and better cosmetic results brought about by minimally invasive applications further increase their preference. One of these approaches is hysteroscopic interventions. Although hysteroscopy is a well-defined method, current research has focused on further reduction of pain. One of these methods is to warm the distention media at body temperature. theTaim of this study was to examine the effect of distention medium temperature on image quality, hyponatremia risk, and post-operative pain in operative hysteroscopy.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Operative Hysteroscopy 24 Centigrade Degree
  • Procedure: Operative Hysteroscopy 37 Centigrade Degree
N/A

Detailed Description

Minimally invasive applications are seen as the gold standard in today's gynecology practice and are frequently preferred by both patients and physicians. Less pain, shorter hospital stays, and better cosmetic results brought about by minimally invasive applications further increase their preference. One of these approaches is hysteroscopic interventions. Although hysteroscopy is a well-defined method, current research has focused on further reduction of pain. One of these methods is to warm the distention media at body temperature.

The optimum distention medium temperature has not been determined in the "Best Practice in Outpatient Hysteroscopy Green Top Guideline" organized by The Royal College of Obstetricians and Gynecologists and "Guideline on Management of Fluid Distension Media in Operative Hysteroscopy" organized by the European Society of Gynecological Endoscopy (1,2). In routine practice, some physicians use distention fluid at room temperature, while others use it by warming it at body temperature. It is known that colder fluids cause irregular contractions in the uterus (3). In prospective studies, the effects of heating distention media at body temperature on pain were reported inconsistently (3,4). As clear data could not be obtained, the risk of further intravasation and hyponatremia that may occur with the image quality and, more importantly, the heating of the fluid was ignored. But; Freitas Fonseca et al. In his in vitro study in Brazil, it was shown by theoretical calculations that heating hysteroscopy irrigation fluids from 270C to 370C increased intravasation by 53%.

In light of the literature, and based on the ideas and possible risks in question, the aim of this study was to examine the effect of distention medium temperature on image quality, hyponatremia risk, and post-operative pain in operative hysteroscopy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
244 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective Randomized Controlled Clinical StudyProspective Randomized Controlled Clinical Study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk and Post-operative Pain in Operative Hysteroscopy
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2025
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 24 Centigrade Degree

Operative hysteroscopy will be performed at room temperature distention medium.

Procedure: Operative Hysteroscopy 24 Centigrade Degree
Operative hysteroscopy will be performed at room temperature distention medium.

Active Comparator: 37 Centigrade Degree

Operative hysteroscopy will be performed using a heated distention medium.

Procedure: Operative Hysteroscopy 37 Centigrade Degree
Operative hysteroscopy will be performed using a heated distention medium.

Outcome Measures

Primary Outcome Measures

  1. Post-operative pain [3 hours]

    Post operative pain will evalute with numeric pain rating scale

Secondary Outcome Measures

  1. Post operavite Na Value [1 minute]

    Post-operative blood Na value will be checked.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • To be planned for operative hysteroscopy due to an endometrial polyp or type 0-1 myoma in the range of 2-3 cm

  • Having a vaginal delivery at least once before

  • Ability to communicate adequately in Turkish or English

Exclusion Criteria:
  • Pregnancy

  • Active vaginal, and cervical infection

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ege University

Investigators

  • Principal Investigator: Sabahattin A Ari, Asst. Prof., Izmir Bakircay University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sabahattin Anıl Arı, Asst. Prof., Izmir Bakircay University
ClinicalTrials.gov Identifier:
NCT05973045
Other Study ID Numbers:
  • 617
First Posted:
Aug 2, 2023
Last Update Posted:
Aug 2, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sabahattin Anıl Arı, Asst. Prof., Izmir Bakircay University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2023