Surgical Approach to Uterine Septum: A Randomized Controlled Trial
| Registry | NCT06315582 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 40 (Estimated) |
| Sponsor | Northwestern University (Other) |
| Conditions | Uterine Septum, Surgical Complication, Septum; Uterus, Treatment Side Effects, Treatment |
| Interventions | Removal of uterine septum with hysteroscopic scissors without electrosurgery., Hysteroscopic septoplasty utilizing bipolar electrosurgery (Procedure) |
| Dates | start 2024-03-11, primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2024-03-18, last updated 2026-06-01 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Uterine Septum All trials for Surgical Complication All trials of Removal of uterine septum with hysteroscopic scissors without electrosurgery. All trials of Hysteroscopic septoplasty utilizing bipolar electrosurgery
The objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. The investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures.
This study is being done to compare two different surgical techniques that can be used to remove the uterine septum. At Northwestern, both procedures are done routinely. Surgeon preference and comfort dictates which is offered. Both techniques are thought to achieve the same goal of removing the participants septum with a procedure called a hysteroscopy in which the participants are taken to the operating room and a scope with a camera is inserted inside their uterus while it is expanded with sterile water. The difference is the instrument used to remove the septum. One technique uses scissors without electricity or heat followed by removal of the excess tissue with a thin tube using suction. The other technique uses an electrical loop (electrosurgery) to cut and remove the tissue. The investigators will be comparing these two procedures by measuring things such as operative time, cost, and the amount of fluid (saline) the participants body absorbs. As mentioned above, to visualize the inside of the participants uterus, the investigators will expand it by filling it with saline.Some of this fluid is absorbed by the walls of the uterus and is routinely measured. This will be one of the measurements used to compare the two surgical techniques.
About 4 weeks after the participants procedure they will have a routine follow up visit to determine if there is any septum left. The investigators will do this by doing an in-office hysteroscopy at this appointment. This might be a simple vaginal ultrasound, ultrasound with saline or a follow up hysteroscopy. If there remains some septum, it would be removed during a second hysteroscopy. It is common to need a second or even third procedure to completely remove the septum. The investigators anticipate the two techniques being compared will have similar success rates in removing the uterine septum, although there is some data to suggest that the current standard of care procedure which is using electrosurgery could cause additional adhesive disease and require another procedure to remove the adhesions. Currently, there is little data comparing these two techniques and so this study will help us understand if one causes more adhesions or not.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Study Intervention A (control group) | Active comparator | Procedure: Hysteroscopic septoplasty utilizing bipolar electrosurgery | Hysteroscopic septoplasty utilizing bipolar electrosurgery |
| Study Intervention B (study group) | Experimental | Procedure: Removal of uterine septum with hysteroscopic scissors without electrosurgery. | Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue |
Sex: Female, ages: 22 Years to 44 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Northwestern Medicine Prentice Women's Hospital | Chicago, Illinois | United States | Recruiting |