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

112 Participants Needed

Trial Summary

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 data supports the idea that Solution Temperature for Hysteroscopic Surgery is an effective treatment?

The available research shows that using warmed saline during hysteroscopic surgery can reduce pain compared to room temperature saline. Several studies compared pain levels during the procedure and found that patients experienced less discomfort with warmed saline. This suggests that adjusting the temperature of the saline can make the treatment more comfortable for patients, which is an important measure of its effectiveness. ^{1 2 3 4 5}

What safety data exists for using different temperatures of saline in hysteroscopic surgery?

The studies primarily focus on comparing pain levels, ease of procedure, and patient satisfaction when using saline at different temperatures during hysteroscopy. They suggest that the temperature of the saline can affect procedural discomfort and patient satisfaction, but do not directly address safety concerns. However, they emphasize the importance of careful fluid monitoring regardless of the medium used. ^{1 2 4 5 6}

Is using different temperatures of 0.9% Saline a promising treatment for hysteroscopic surgery?

Yes, using different temperatures of 0.9% Saline for hysteroscopic surgery can be promising. Studies suggest that warming the saline can improve patient comfort by reducing pain during the procedure. It may also enhance the clarity of the view for doctors, making the surgery easier and potentially more effective. ^{1 2 4 5 7}

What is the purpose of this trial?

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.

Research Team

Aya Mohr-Sasson

Principal Investigator

The University of Texas Health Science Center, Houston, TX

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. India 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. [2022]

2. Australia 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Investigation of often-reported ten percent hysteroscopy fluid overfill: is this accurate? [2015]

4. Singapore 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Diagnostic hysteroscopy using liquid distention medium: comparison of pain with warmed saline solution vs room-temperature saline solution. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Hysteroscopic endometrial ablation using free heated saline for the treatment of menorrhagia. [2019]