Comparing two surgical methods for removing uterine septum
Surgical Approach to Uterine Septum: A Randomized Controlled Trial
This study is testing two different surgical methods for removing a uterine septum to see which one works better and has fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 22 Years to 44 Years |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06315582 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two surgical techniques for resecting a uterine septum: one using scissors without electrosurgery and the other utilizing bipolar electrosurgery. Both procedures are performed under hysteroscopy, where a camera is inserted into the uterus, and the septum is removed. The study will evaluate various factors including operative time, complication rates, and the absorption of saline fluid during the procedure. Follow-up assessments will be conducted to check for any remaining septum after four weeks.
Who should consider this trial
Good fit: Ideal candidates are women aged 20-44 with a confirmed uterine septum greater than 1.0 cm.
Not a fit: Patients with known tubal disease, significant bleeding disorders, or concurrent laparoscopic procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more efficient surgical option for women with uterine septum.
How similar studies have performed: Previous studies have shown varying success with different surgical techniques for uterine septum resection, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Have a confirmed septum (\>1.0 cm) confirmed with 3D imaging and/or MRI * 20-44 years old Exclusion criteria * Known tubal disease * Bleeding diastasis * No blood thinners * No concurrent laparoscopy scheduled * Patient with confirmed fibroids over \>1 cm FIGO (International Federation of Gynecology and Obstetrics) type 1
Where this trial is running
Chicago, Illinois
- Northwestern Medicine Prentice Women's Hospital — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Sarah L Rodriguez, MD
- Email: sarah.rodriguez@nm.org
- Phone: 7863011284
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.