Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315582
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-02-27
Brief Title:
Surgical Approach to Uterine Septum
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Surgical Approach to Uterine Septum A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 salineSome 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None