Septum; Uterus, Surgical Complication, Treatment, Treatment Side Effects, Uterine Septum
Conditions
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.
Interventions
PROCEDURERemoval of uterine septum with hysteroscopic scissors without electrosurgery.
Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue
PROCEDUREHysteroscopic septoplasty utilizing bipolar electrosurgery
Hysteroscopic septoplasty utilizing bipolar electrosurgery
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
Intervention model description
Randomized single blinded study
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Comparing patient recovery and satisfaction | 2 days postop | Comparing patient recovery and satisfaction with follow up post-operative phone calls with standardized questions |
Countries
United States
Contacts
CONTACTSarah L Rodriguez, MD
CONTACTMilad Madgy, MD
Outcome results
None listed