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Completed

NCT Number: NCT07064850

Vasomotor Symptoms in Post-Hysterectomy Women With Ovarian Conservation

The purpose of this study is to learn about vasomotor symptoms (such as hot flashes and night sweats) in the short-term period after a hysterectomy.

The main question it aims to answer is: How common and severe are vasomotor symptoms shortly after surgery in people who have had a hysterectomy?

Participants will complete a survey before surgery to assess baseline symptoms, and again 2 weeks after surgery to see if there are any changes.

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Key information

Conditions

Age range

35 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60126, United States

About this study

Hysterectomies are among the most common surgical procedures for women in the United States, with approximately 600,000 operations performed annually. Traditionally, it has been assumed that retaining one or both ovaries during hysterectomy mitigates the onset and severity of vasomotor symptoms, such as hot flashes and night sweats. However, recent research indicates that even with ovarian conservation, women may experience a higher incidence of persistent vasomotor symptoms compared to those who have not had the surgery. These symptoms can significantly impact quality of life, underscoring the need for comprehensive studies that track the progression of vasomotor symptoms post-hysterectomy. Despite their clinical importance, the precise timeline of symptom onset and the influence of ovarian retention remain poorly understood.

Existing studies on surgical menopause primarily focus on factors such as depression, anxiety, and abdominal pain. No study to date has followed women from the immediate postoperative period through the subsequent months to assess the onset, type, and frequency of vasomotor symptoms. Additionally, research on surgical menopause often lacks detailed information on the diagnostic indications for hysterectomy and fails to differentiate between women who retained both ovaries versus those who retained only one at the time of surgery. This study aims to provide a better understanding of the relationship between the onset and severity of vasomotor symptoms in order to improve postoperative care, guide patient counseling, and develop targeted interventions to mitigate vasomotor symptoms.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 35-50 years old
  • Undergoing hysterectomy with at least one ovary conserved
  • Ability to provide informed consent

Exclusion criteria

(None specified)

Treatment and study plan

Primary outcomes

  1. Changes in Vasomotor Symptom Frequency

    Time frame: Baseline period to 2 weeks pre-operative

    One primary outcome measure is the change in average vasomotor symptom frequency score from baseline (pre-operative) to 2 weeks post-operative. The symptoms evaluated will be hot flashes, night sweats, increased sweating, sleep disturbances, and heart palpitations. Participants will rate how often they experience each symptom: never, rarely, sometimes, or often. For each symptom, average scores at baseline will be compared to scores collected 2 weeks after surgery to assess changes in symptom frequency.

  2. Changes in Vasomotor Symptom Distress

    Time frame: Baseline period to 2 weeks pre-operative

    One primary outcome measure is the change in average vasomotor symptom distress scores from baseline (pre-operative) to 2 weeks post-operative. The symptoms assessed will include hot flashes, night sweats, increased sweating, sleep disturbances, and heart palpitations. Participants will rate how bothersome each symptom is using a 7-point Likert scale (0 = not at all bothersome, 6 = extremely bothersome). For each symptom, average distress scores at baseline will be compared to those collected 2 weeks post-operatively to evaluate changes in perceived symptom burden. Higher scores indicate greater symptom distress.

Secondary outcomes

  1. Thematic Analysis of Patient-Reported Symptom Experiences

    Time frame: Baseline period to 2 weeks post-operative

    This secondary outcome measure involves the qualitative analysis of patient comments related to symptom experiences. Participants will have the option to provide open-ended feedback in both the pre-operative and post-operative surveys. The qualitative data will focus on the same vasomotor symptoms assessed quantitatively (hot flashes, night sweats, increased sweating, sleep disturbances, and heart palpitations), as well as any additional symptoms reported after surgery. Patient narratives will be analyzed using thematic analysis to identify recurring themes and the overall impact of symptoms on daily life. This qualitative component is intended to provide contextual depth to the quantitative symptom distress scores.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Vasomotor Symptoms in Post-Hysterectomy Women With Ovarian Conservation: A Prospective Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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