Surgical Approach to Uterine Septum

Not Applicable

Recruiting

• Conditions: Treatment Side Effects; Uterine Septum; Surgical Complication; Septum; Uterus; Treatment
• Interventions: Procedure: Hysteroscopic septoplasty utilizing bipolar electrosurgery; Procedure: Removal of uterine septum with hysteroscopic scissors without electrosurgery.

• Registration Number: NCT06315582
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-27
• Study Start: 2024-03-11
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-08-26
• Study Completion: 2026-02-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Intervention A (control group)	Hysteroscopic septoplasty utilizing bipolar electrosurgery	Hysteroscopic septoplasty utilizing bipolar electrosurgery
Study Intervention B (study group)	Removal of uterine septum with hysteroscopic scissors without electrosurgery.	Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue

Primary Outcome Measures

Name	Time	Method
Procedure-level variables: operative time hysteroscopic septoplasty	During the intervention/procedure/surgery	We will measure time it takes to conduct procedure
Procedure-level variables: Surgical Cost	During the surgery	We will compare amount of money spent.
Procedure-level variables: Fluid deficit	During the surgery	We will measure amount of fluid deficit which is a number that is generate by hysteroscope.
Resolution of uterine septum	Assess at 4 weeks post-op hysteroscopy	Compare septum resolution defined by being less than 1 cm in depth from the intertubal line and need for additional intervention following hysteroscopic septoplasty utilizing these two surgical techniques

Secondary Outcome Measures

Name	Time	Method
Comparing patient recovery and satisfaction	2 days postop	Comparing patient recovery and satisfaction with follow up post-operative phone calls with standardized questions
Compare adverse events	Immediate period-- 1 week post-operation	Characterize and compare any potential adverse events related to the two surgical techniques for hysteroscopic septoplasty

Trial Locations

Locations (1)

Northwestern Medicine Prentice Women's Hospital; 🇺🇸 Chicago, Illinois, United States