Clinical trial NCT06315582: Surgical Approach to Uterine Septum
Official title: Surgical Approach to Uterine Septum: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uterine Septum
Surgical Complication
Septum; Uterus
Treatment Side Effects
Treatment
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized single blinded study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Procedure-level variables: operative time hysteroscopic septoplasty
timeFrame: During the intervention/procedure/surgery
measure: Procedure-level variables: Surgical Cost
timeFrame: During the surgery
measure: Procedure-level variables: Fluid deficit
timeFrame: During the surgery
measure: Resolution of uterine septum
timeFrame: Assess at 4 weeks post-op hysteroscopy
Secondary outcomes:
measure: Compare adverse events
timeFrame: Immediate period-- 1 week post-operation
measure: Comparing patient recovery and satisfaction
timeFrame: 2 days postop
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine Prentice Women's Hospital
state: Illinois
Study officials:
References:
citation: Fatehi Hassanabad A, Zarzycki AN, Jeon K, Dundas JA, Vasanthan V, Deniset JF, Fedak PWM. Prevention of Post-Operative Adhesions: A Comprehensive Review of Present and Emerging Strategies. Biomolecules. 2021 Jul 14;11(7):1027. doi: 10.3390/biom11071027.
citation: Carrera M, Perez Millan F, Alcazar JL, Alonso L, Caballero M, Carugno J, Dominguez JA, Moratalla E. Effect of Hysteroscopic Metroplasty on Reproductive Outcomes in Women with Septate Uterus: Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2022 Apr;29(4):465-475. doi: 10.1016/j.jmig.2021.10.001. Epub 2021 Oct 11.
citation: LaMonica R, Pinto J, Luciano D, Lyapis A, Luciano A. Incidence of Septate Uterus in Reproductive-Aged Women With and Without Endometriosis. J Minim Invasive Gynecol. 2016 May-Jun;23(4):610-3. doi: 10.1016/j.jmig.2016.02.010. Epub 2016 Feb 23.
citation: Kalaitzopoulos DR, Themeli MZ, Grigoriadis G, Alterio MD, Vitale SG, Angioni S, Daniilidis A. Fertility, pregnancy and perioperative outcomes after operative hysteroscopy for uterine septum: a network meta-analysis. Arch Gynecol Obstet. 2024 Mar;309(3):731-744. doi: 10.1007/s00404-023-07109-2. Epub 2023 Jun 24.
citation: Practice Committee of the American Society for Reproductive Medicine. Electronic address: ASRM@asrm.org; Practice Committee of the American Society for Reproductive Medicine. Uterine septum: a guideline. Fertil Steril. 2016 Sep 1;106(3):530-40. doi: 10.1016/j.fertnstert.2016.05.014. Epub 2016 May 25.
citation: Dason ES, Mathur S, Murji A. Hysteroscopic septoplasty: many techniques, little evidence. Fertil Steril. 2021 Nov;116(5):1426-1427. doi: 10.1016/j.fertnstert.2021.09.001. Epub 2021 Oct 1. No abstract available.
citation: Budden A, Abbott JA. The Diagnosis and Surgical Approach of Uterine Septa. J Minim Invasive Gynecol. 2018 Feb;25(2):209-217. doi: 10.1016/j.jmig.2017.07.017. Epub 2017 Jul 26.
citation: Yang L, Wang L, Chen Y, Guo X, Miao C, Zhao Y, Li L, Zhang Q. Cold scissors versus electrosurgery for hysteroscopic adhesiolysis: A meta-analysis. Medicine (Baltimore). 2021 Apr 30;100(17):e25676. doi: 10.1097/MD.0000000000025676.