Surgical Approach to Uterine Septum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2026-02-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Uterine Septum Surgical Complication Septum; Uterus Treatment Side Effects Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized single blinded study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Participants will be randomized using www.randomizer.org algorithm. They will be assigned to arm in the operating room where they will get that intervention. When they get to Post Anesthesia Care Unit, they will be unblinded. Surgeon will be blinded until patient is in operating room and envelope with randomization is opened.

Study Groups

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Study Intervention A (control group)

Hysteroscopic septoplasty utilizing bipolar electrosurgery

Group Type ACTIVE_COMPARATOR

Hysteroscopic septoplasty utilizing bipolar electrosurgery

Intervention Type PROCEDURE

Hysteroscopic septoplasty utilizing bipolar electrosurgery

Study Intervention B (study group)

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

Group Type EXPERIMENTAL

Removal of uterine septum with hysteroscopic scissors without electrosurgery.

Intervention Type PROCEDURE

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

Interventions

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Removal of uterine septum with hysteroscopic scissors without electrosurgery.

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

Intervention Type PROCEDURE

Hysteroscopic septoplasty utilizing bipolar electrosurgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes