Surgical Approach to Uterine Septum

Northwestern University

Status: Enrolling

Conditions: Treatment; Treatment Side Effects; Uterine Septum; Surgical Complication; Septum; Uterus

Treatments: Procedure: Removal of uterine septum with hysteroscopic scissors without electrosurgery.; Procedure: Hysteroscopic septoplasty utilizing bipolar electrosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06315582

STU00220487

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 22 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Study Intervention A (control group)

Active Comparator group

Description:

Hysteroscopic septoplasty utilizing bipolar electrosurgery

Treatment:

Procedure: Hysteroscopic septoplasty utilizing bipolar electrosurgery

Study Intervention B (study group)

Experimental group

Description:

Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue

Treatment:

Procedure: Removal of uterine septum with hysteroscopic scissors without electrosurgery.