Menstrual cycle effects on optic nerve sheath diameter during laparoscopic gynecologic surgery
Official title: The Effect of Menstrual Cycle Phase on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Gynecologic Surgery
Run by Konya City Hospital · NCT07539831 · Data updated 2026-11-12
This study will try to see if menstrual cycle phase changes the optic nerve sheath size and affects postoperative nausea, vomiting, and thinking in women having elective laparoscopic gynecologic surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 110 (estimated) |
| Sponsor | Konya City Hospital Academic / other |
| Locations | 1 site (Konya) |
| Status | Recruiting |
| Started | April 20, 2026 |
| Main results expected | March 3, 2027 |
| Study ends | April 5, 2027 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT07539831 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–45 with regular menstrual cycles, ASA physical status I–II, scheduled for elective laparoscopic gynecologic surgery during either the follicular or luteal phase.
✕Probably not a fit
Patients outside the age range, with irregular cycles (for example PCOS or early menopause), who are pregnant or breastfeeding, or who have neurological/ocular conditions affecting intracranial pressure, prior brain surgery, or uncontrolled severe cardiovascular disease are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this single-site observational study at Konya City Hospital, women aged 18–45 scheduled for elective laparoscopic gynecologic surgery will be grouped by menstrual phase (follicular versus luteal). Perioperative optic nerve sheath diameter (ONSD) measurements will be taken and postoperative nausea and vomiting plus cognitive function (using the Mini-Mental State Examination and verbal descriptive scales) will be recorded. Key exclusions include irregular menstrual cycles, pregnancy or breastfeeding, neurological or eye diseases affecting intracranial pressure, prior brain surgery, and uncontrolled severe cardiovascular disease. The study aims to see whether normal hormonal fluctuations across the menstrual cycle are associated with differences in ONSD and short-term postoperative outcomes.
Why it matters
Potential benefit: If a link is found, clinicians could tailor perioperative monitoring and care by menstrual phase to potentially reduce postoperative nausea or short-term cognitive changes.
How similar studies have gone: ONSD has been used as a noninvasive marker of intracranial pressure in other settings, but directly testing menstrual cycle effects on ONSD is relatively novel with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients aged 18 to 45 years * Scheduled for elective laparoscopic gynecologic surgery * Menstrual cycle in the follicular phase or luteal phase * American Society of Anesthesiologists (ASA) physical status I-II Exclusion Criteria: * Irregular menstrual cycle (e.g., polycystic ovary syndrome, early menopause, hypothalamic amenorrhea) * Pregnancy or breastfeeding * Neurological disease associated with intracranial pressure changes * Glaucoma or another eye disease associated with high intraocular pressure * Previous brain surgery * Uncontrolled hypertension or severe cardiovascular disease
Where it's running
-
Konya City Hospital
Konya, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Mahmut Tutar, Md — Konya City Hospital
- Study coordinator: Mahmut Tutar, Md
- Email: masatu42@gmail.com
- Phone: 905552723704
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.