NCT05622097

Brief Summary

Hysteroscopic surgery is widely used for the treatment of gynecological diseases, such as septum, synechiae, polyp and intrauterine fibroids. The complication rate is estimated as 0.22% and includes uterine perforation, massive bleeding, and fluid overload. Operative hysteroscopy intravascular absorption (OHIA) syndrome refers to fluid overload complications from operative hysteroscopies and is considered a major complication. Report describing the clinical association between irrigation fluid temperature to intravasation rate itself or the risk of fluid overload are limited mainly to theoretical models. Due to the aforementioned, we aim to evaluated the role of temperature on absorption of the irrigation solution in hysteroscopic surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

November 10, 2022

Last Update Submit

April 7, 2025

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • Median time to reach deficit of 100 cc

    The difference to reach deficit of 100 cc in each arm

    From recruitment until follow up visit 2 weeks post operation

Secondary Outcomes (2)

  • Visual analog scale (VAS)

    1 hour after the procedure

  • Total fluid deficit

    The time from the beginning to the end of the procedure

Study Arms (2)

Warmed saline

EXPERIMENTAL

0.9% Saline will be warmed to 37 degrees Celsius

Other: 0.9% Saline warmed to 37 degrees Celsius

Room temperature saline

EXPERIMENTAL

0.9% Saline will be warmed to 24 degrees Celsius

Other: 0.9% Saline warmed to 24 degrees Celsius

Interventions

0.9% Saline warmed to 37 degrees CelsiusOTHER

0.9% Saline warmed to 37 degrees Celsius

Warmed saline
0.9% Saline warmed to 24 degrees CelsiusOTHER

0.9% Saline warmed to 24 degrees Celsius

Room temperature saline

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHysteroscopy is performed only in women with uterus
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- All women undergoing gynecologic hysteroscopic surgery.

You may not qualify if:

  • Women with known malignancy
  • hysteroscopic procedures using alternative solutions (Ringer's lactate, 1.5% glycine, 5% dextrose)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas

Houston, Texas, 77030, United States

Location

Related Publications (5)

  • Lee EB, Park J, Lim HK, Kim YI, Jin Y, Lee KH. Complications of fluid overload during hysteroscopic surgery: cardiomyopathy and epistaxis - A case report. Anesth Pain Med (Seoul). 2020 Jan 31;15(1):61-65. doi: 10.17085/apm.2020.15.1.61.

    PMID: 33329791RESULT

  • Aydeniz B, Gruber IV, Schauf B, Kurek R, Meyer A, Wallwiener D. A multicenter survey of complications associated with 21,676 operative hysteroscopies. Eur J Obstet Gynecol Reprod Biol. 2002 Sep 10;104(2):160-4. doi: 10.1016/s0301-2115(02)00106-9.

    PMID: 12206931RESULT

  • Wang MT, Chang CC, Hsieh MH, Chang CW, Fan Chiang YH, Tsai HC. Operative hysteroscopy intravascular absorption syndrome is more than just the gynecological transurethral resection of the prostate syndrome: A case series and literature review. Taiwan J Obstet Gynecol. 2020 Sep;59(5):748-753. doi: 10.1016/j.tjog.2020.07.022.

    PMID: 32917330RESULT

  • Hahn RG. Fluid absorption in endoscopic surgery. Br J Anaesth. 2006 Jan;96(1):8-20. doi: 10.1093/bja/aei279. Epub 2005 Nov 29.

    PMID: 16317031RESULT

  • Tuchschmid S, Bajka M, Szczerba D, Lloyd B, Szekely G, Harders M. Modelling intravasation of liquid distension media in surgical simulators. Med Image Comput Comput Assist Interv. 2007;10(Pt 1):717-24. doi: 10.1007/978-3-540-75757-3_87.

    PMID: 18051122RESULT

Study Officials

  • Aya Mohr-Sasson

    The University of Texas Health Science Center, Houston, TX

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

November 10, 2022

First Posted

November 18, 2022

Study Start

December 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

April 8, 2025

Record last verified: 2025-04

Locations

US(1)