Northwestern Medicine Prentice Women's Hospital
Chicago, Illinois, 60611, United States
Location status: Recruiting
NCT Number: NCT06315582
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.
Interested in participating?
Request Info22 year–44 year
Female
Interventional
Not applicable
Chicago, Illinois, 60611, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue
Hysteroscopic septoplasty utilizing bipolar electrosurgery
Time frame: During the intervention/procedure/surgery
We will measure time it takes to conduct procedure
Time frame: During the surgery
We will compare amount of money spent.
Time frame: During the surgery
We will measure amount of fluid deficit which is a number that is generate by hysteroscope.
Time frame: 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
Time frame: Immediate period-- 1 week post-operation
Characterize and compare any potential adverse events related to the two surgical techniques for hysteroscopic septoplasty
Time frame: 2 days postop
Comparing patient recovery and satisfaction with follow up post-operative phone calls with standardized questions
Contact information is provided by the study sponsor or research team.
Milad Madgy, MD
CONTACT
Sarah L Rodriguez, MD
CONTACT
Northwestern University
Other
Surgical Approach to Uterine Septum: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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