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SurgerySTOFDNCT05622097

Solution Temperature and Fluid Deficit During Hysteroscopy

A study testing 0.9% Saline warmed to 37 degrees Celsius and 0.9% Saline warmed to 24 degrees Celsius in people with Surgery, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Surgery
What is being tested?
0.9% Saline warmed to 37 degrees Celsius and 0.9% Saline warmed to 24 degrees Celsius
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteUnited States
Study dates
1 Dec 2023to 1 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All women undergoing gynecologic hysteroscopic surgery.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Texas

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: The Influence of Solution Temperature on Fluid Deficit During Hysteroscopy

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.

Read the detailed description

Hysteroscopic surgery is widely used for the treatment of gynecological diseases, such as septum, synechiae, polyp and intrauterine fibroids. Advantages include less invasiveness and faster recovery compared to traditional laparotomy. 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. Although rare, large-scale fluid absorption might lead to symptoms severe enough to require intensive care including dilutional hyponatremia, hypoosmolality, brain oedema, hypokinetic circulation and cardiovascular collapse.

During surgical resection, hydrostatic pressure is usually higher than intravascular pressures, mainly in the venous bed, allowing intravasation of irrigation solution from the surgical field to the intravascular space. The greater the difference between these hydrostatic pressures, the higher the flow rate into the blood and the higher the risk of fluid overload. Moreover, although it is important to control surgical time and to keep distension pressure as low as possible, fluid overload may occur before the predicted period.

Preventive measures, such as low-pressure irrigation, might reduce the extent of fluid absorption but does not eliminate this complication. Monitoring the extent of absorption during surgery allows control of the fluid balance in the individual patient.

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. Benefits of cold irrigation fluids are reported in studies on transurethral prostatic resection (TUR) and include shorter procedure duration, improved surgical visualization, less fluid use and reduced blood loss. The results of studies demonstrating higher complication rate with hypothermia caused by locally applied cold irrigation solutions are equivocal and were not demonstrated specifically in hysteroscopic procedures.

The application of warm distension fluid has been recently used in office hysteroscopy in order to reduce pain severity. A recent meta-analysis including 5 randomized control trials reported warm saline was linked to a significant reduction in the visual analog scale (VAS) pain score during the procedure and higher patient satisfaction rate. Nevertheless, warm irrigation solution might be limiting for longer procedures due to expected expansion of the vascular system resulting higher fluid deficit in shorter time.

Due to the aforementioned, we aim to evaluated the role of temperature on absorption of the irrigation solution in hysteroscopic surgery.

Material and Methods This is a prospective study that will be conducted at a single tertiary medical center. Study population will include all women undergoing hysteroscopic surgery due to benign indication. Women with known malignancy or hysteroscopic procedures using alternative solutions (Ringer's lactate, 1.5% glycine, 5% dextrose) will be excluded from the study.

A TruClear™ hysteroscope will be used with 0.9% saline solution as the expanding media. Three different temperatures will be randomly assigned to each case including: room temperature (24°C), and body temperature (37°C). The distension fluid will be prepared in advance using heating incubator for both solutions temperatures. The liquid temperatures will be confirmed by thermometer before the procedure. Randomization to each arm will be made using computer randomizer. The time to reach fluid deficit will be measured at the following deficit points: 100cc,150cc, 250 cc, 500 cc, 750 cc, 1000cc, 1500 cc and total deficit. In addition, presurgical and post-surgical blood samples for sodium level and osmolality will be collected. Immediate post-surgical pain will be assesses 1 hour following the procedure using the visual analog scale.

Demographic and clinical characteristics will be drawn from women's medical files. Operative and post-operative data will be collected including: operation indication, operation duration, operation complications (uterine perforation, bleeding, fluid overload complications- electrolyte disturbances, osmolality, pulmonary embolism, pulmonary oedema), post-operative complications (hemorrhage, endometritis, vascular - thromboembolic event, ileus).

Conditions
Surgery
Being tested
0.9% Saline warmed to 37 degrees Celsius, 0.9% Saline warmed to 24 degrees Celsius

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.9% Saline warmed to 37 degrees CelsiusOther

    0.9% Saline warmed to 37 degrees Celsius

  • 0.9% Saline warmed to 24 degrees CelsiusOther

    0.9% Saline warmed to 24 degrees Celsius

Study groups in NCT05622097
Study groupRoleWhat they receive
Warmed salineExperimental0.9% Saline will be warmed to 37 degrees Celsius
Receives: Other: 0.9% Saline warmed to 37 degrees Celsius
Room temperature salineExperimental0.9% Saline will be warmed to 24 degrees Celsius
Receives: Other: 0.9% Saline warmed to 24 degrees Celsius

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median time to reach deficit of 100 cc

    The difference to reach deficit of 100 cc in each arm

    Measured: From recruitment until follow up visit 2 weeks post operation

Secondary outcomes (2)
  1. Visual analog scale (VAS)

    To estimate pain post operation on a scale of 1 to 10 while 1 is no pain and 10 is maximal pain

    Measured: 1 hour after the procedure

  2. Total fluid deficit

    To estimate the time to complete the procedure and the total deficit.

    Measured: The time from the beginning to the end of the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2022
  2. Study start1 Dec 2023
  3. Primary completion1 Jul 2024
  4. Study completion1 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05622097
Sponsor's protocol ID
HSC-MS-22
Acronym
STOFD
Status last verified
Apr 2025
First submitted
10 Nov 2022
Last updated
8 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33329791
  • 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.

    PubMed 12206931
  • 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.

    PubMed 32917330
  • 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.

    PubMed 16317031
  • 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.

    PubMed 18051122

Questions about this trial

What is this clinical trial studying?

A study testing 0.9% Saline warmed to 37 degrees Celsius and 0.9% Saline warmed to 24 degrees Celsius in people with Surgery, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median time to reach deficit of 100 cc (time frame: From recruitment until follow up visit 2 weeks post operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05622097, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.

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