Solution Temperature for Hysteroscopic Surgery

(STOFD Trial)

Overseen By Aya Mohr-Sasson

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Malignancy, Alternative solutions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the temperature of a saline solution used during hysteroscopic surgery (a procedure to treat conditions inside the uterus) impacts fluid absorption. The goal is to determine if the solution's temperature affects the risk of fluid overload, a complication that can cause issues like bleeding. The trial will test saline at three different temperatures: cold, room temperature, and body temperature. Women undergoing hysteroscopic surgery, who are not using certain alternative solutions, might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance surgical safety and outcomes.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for hysteroscopic surgery?

Research has shown that using 0.9% saline during hysteroscopic surgery is generally safe, with a low complication rate of about 0.22%. Possible risks include a tear in the uterus, heavy bleeding, and excessive fluid absorption. Excessive fluid absorption can occur if the body takes in too much of the liquid used during the procedure. However, no cases of OHIA syndrome have been reported with saline use.

Using warm saline at 37 degrees Celsius can reduce pain compared to room temperature saline. Both warm and room temperature saline have been used without serious problems. Still, there is a risk of excessive fluid absorption if the surgery takes too long or uses too much liquid. Overall, 0.9% saline at these temperatures appears to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how the temperature of saline solutions used in hysteroscopic surgery might impact outcomes. Unlike current practices that don't typically consider temperature variations, this trial investigates saline solutions at three different temperatures: cooled to 17 degrees Celsius, warmed to 24 degrees Celsius, and further warmed to 37 degrees Celsius. By doing so, the trial aims to discover if altering the temperature could enhance surgical precision, reduce discomfort, or improve recovery times. This could lead to a more tailored approach in hysteroscopic procedures, potentially offering more comfort and better results for patients.

What evidence suggests that this trial's treatments could be effective for reducing fluid overload in hysteroscopic surgery?

This trial will compare the effects of different saline temperatures during hysteroscopic surgery. Research has shown that warmed saline can reduce pain more effectively than room-temperature saline. Participants may receive 0.9% saline warmed to either 37 degrees Celsius or 24 degrees Celsius. Warm fluids generally provide more comfort, aiding in pain management. Studies have found both 37°C (body temperature) and 24°C saline effective, but more evidence supports warmer fluids for comfort. However, fluid overload, which occurs when the body absorbs too much fluid, poses a risk. Monitoring fluid absorption during surgery is crucial to avoid complications. Overall, using warmer saline appears promising for pain reduction, but safety measures are essential to prevent fluid-related issues. ^{1 2 3 4 5}

Who Is on the Research Team?

Aya Mohr-Sasson

Principal Investigator

The University of Texas Health Science Center, Houston, TX

Are You a Good Fit for This Trial?

This trial is for women undergoing hysteroscopic surgery, a procedure used to treat various gynecological issues. It's open to all women who are scheduled for this type of surgery.

Inclusion Criteria

I am a woman scheduled for surgery inside my uterus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hysteroscopic surgery with randomly assigned irrigation fluid temperatures

1 day

1 visit (in-person)

Immediate Post-operative Monitoring

Participants are monitored for immediate post-surgical pain and fluid deficit

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 0.9% Saline cooled to 17 degrees Celsius
• 0.9% Saline warmed to 24 degrees Celsius
• 0.9% Saline warmed to 37 degrees Celsius
• Hysteroscopic surgery

Trial Overview The study is testing the effects of irrigation fluid temperature on fluid absorption during hysteroscopy. Participants will receive saline warmed to either 37 degrees Celsius or 24 degrees Celsius to see if temperature affects the risk of fluid overload.

How Is the Trial Designed?

Group I: Warmed saline Experimental Treatment 1 Intervention

0.9% Saline will be warmed to 37 degrees Celsius

Group II: Room temperature saline Experimental Treatment 1 Intervention

0.9% Saline will be warmed to 24 degrees Celsius

0.9% Saline cooled to 17 degrees Celsius is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Normal Saline for:

• General medical use as a diluent or vehicle for intravenous administration
• Hysteroscopic procedures

Approved in United States as 0.9% Sodium Chloride Solution for:

• General medical use as a diluent or vehicle for intravenous administration
• Hysteroscopic procedures

Approved in Canada as Normal Saline for:

• General medical use as a diluent or vehicle for intravenous administration
• Hysteroscopic procedures

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a study of 64 women undergoing hysteroscopic examinations, using warmed saline solution did not significantly reduce pain intensity compared to room-temperature saline, with pain scores being similar immediately after and at 1 and 15 minutes post-procedure.

Both groups reported high satisfaction rates (84% for warmed saline and 85% for room-temperature saline), indicating that neither temperature of the saline significantly impacted patient satisfaction or the duration of the examination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic hysteroscopy using liquid distention medium: comparison of pain with warmed saline solution vs room-temperature saline solution. Evangelista, A., Oliveira, MA., Crispi, CP., et al.[2015]

In a study of 100 women undergoing outpatient hysteroscopy, using warm normal saline (36°C) as a distention medium did not significantly reduce pain compared to room-temperature saline (25°C), as measured by a visual analogue scale (VAS).

The results indicate that warming the saline does not provide any pain relief during the procedure, regardless of factors like age, menopausal status, or the type of hysteroscopy performed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain assessment during outpatient hysteroscopy using room temperature versus warm normal saline solution as a distention medium - a prospective randomized study. Issat, T., Beta, J., Nowicka, MA., et al.[2020]

The study measured the overfill of irrigation fluids used in hysteroscopy and found that the actual overfill ranged from 2.8% to 5.6%, which is significantly lower than the previously assumed 10%.

This suggests that the risk of complications related to fluid overload may be overestimated, and emphasizes the importance of accurate measurement systems for irrigation fluids during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of often-reported ten percent hysteroscopy fluid overfill: is this accurate? Nezhat, CH., Fisher, DT., Datta, S.[2015]

In a study of 100 women undergoing outpatient hysteroscopy, using warmed saline (37°C) versus room temperature saline (25°C) did not significantly affect the ease of the procedure, clarity of view, or patient discomfort during and after the procedure.

Patient satisfaction and likelihood of recommending the procedure were similar between both groups, indicating that the temperature of the saline used does not impact the overall experience of outpatient hysteroscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does temperature of distending medium matter in outpatient hysteroscopy? A double-blinded cohort control observational study of room temperature versus warmed saline. Kapur, S., Gruber, A., Sekar, H., et al.[2020]

Continuous-flow hysteroscopes and resectoscopes have improved the effectiveness of both diagnostic and therapeutic hysteroscopy procedures.

Saline is recommended as the best distending medium for procedures using mechanical or bipolar instruments, while 5% mannitol is considered the safest option for resectoscopic surgery, highlighting the importance of careful fluid monitoring during these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Instrumentation and distention media for the hysteroscopic treatment of abnormal uterine bleeding. Indman, PD.[2019]

In a study of 100 patients undergoing diagnostic hysteroscopy, using warmed saline (38-40°C) as a distension medium did not significantly reduce pain intensity compared to room temperature saline, as measured by visual analog scale (VAS) scores at various time points during the procedure.

Both groups showed similar levels of procedural acceptance and no significant differences in the time taken or failed procedures, indicating that warming the saline does not enhance the overall experience or effectiveness of the hysteroscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Pain at Different Steps of Diagnostic Hysteroscopy Using Room Temperature Normal Saline versus Warmed Normal Saline Solution as Distension Medium: A Randomized Controlled Trial. Sharma, S., Roy, KK., Rai, R., et al.[2022]

Hysteroscopic endometrial ablation using heated saline was found to be safe, with no complications reported during the procedure among 20 women with menorrhagia.

After 12 months, 55.6% of participants became amenorrheic, indicating that the procedure effectively reduced menstrual flow for many women, making it a promising treatment option for menorrhagia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hysteroscopic endometrial ablation using free heated saline for the treatment of menorrhagia. Weisberg, M., Goldrath, MH., Berman, J., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05622097?draw=2&rank=1

Solution Temperature and Fluid Deficit During Hysteroscopy The complication rate is estimated as 0.22% and includes uterine perforation, massive bleeding, and fluid overload. Operative hysteroscopy intravascular ...

2. withpower.com withpower.com/trial/phase-surgery-11-2022-51b11

Solution Temperature for Hysteroscopic Surgery (STOFD ... The available research shows that using warmed saline during hysteroscopic surgery can reduce pain compared to room temperature saline. Several studies compared ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6676032/

Complications of fluid overload during hysteroscopic surgery Two thousand and ten cubic centimeters of 0.9% normal saline irrigation fluid was measured. ... There were no significant metabolic derangements postoperatively ( ...

4. researchgate.net researchgate.net/publication/7761341_Isotonic_Fluid_Absorption_during_Hysteroscopy_Resulting_in_Severe_Hyperchloremic_Acidosis

Isotonic Fluid Absorption during Hysteroscopy Resulting in ... If the use of isotonic solutions such as 0.9% sodium chloride prevents from dilution hyponatriemia, the risk of fluid overload is still ...

5. ctv.veeva.com ctv.veeva.com/study/solution-temperature-and-fluid-deficit-during-hysteroscopy

Solution Temperature and Fluid Deficit During Hysteroscopy The complication rate is estimated as 0.22% and includes uterine perforation, massive bleeding, and fluid overload. Operative hysteroscopy ...