Surgical Approach to Uterine Septum

Treatment Clinical Trial

Official title:

Surgical Approach to Uterine Septum: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06315582
• Other study ID #: STU00220487
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: February 26, 2026

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Sarah L Rodriguez, MD
• Phone: 7863011284
• Email: sarah.rodriguez[@]nm.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 26, 2026
• Est. primary completion date: August 26, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Septate Uterus
• Septum; Uterus
• Surgical Complication
• Treatment
• Treatment Side Effects
• Uterine Septum

Intervention

Procedure:
• Removal of uterine septum with hysteroscopic scissors without electrosurgery.
Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue
• Hysteroscopic septoplasty utilizing bipolar electrosurgery
Hysteroscopic septoplasty utilizing bipolar electrosurgery

Locations

Country	Name	City	State
United States	Northwestern Medicine Prentice Women's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. 2 — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure-level variables: operative time hysteroscopic septoplasty	We will measure time it takes to conduct procedure	During the intervention/procedure/surgery
Primary	Procedure-level variables: Surgical Cost	We will compare amount of money spent.	During the surgery
Primary	Procedure-level variables: Fluid deficit	We will measure amount of fluid deficit which is a number that is generate by hysteroscope.	During the surgery
Primary	Resolution of uterine septum	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	Assess at 4 weeks post-op hysteroscopy
Secondary	Compare adverse events	Characterize and compare any potential adverse events related to the two surgical techniques for hysteroscopic septoplasty	Immediate period-- 1 week post-operation
Secondary	Comparing patient recovery and satisfaction	Comparing patient recovery and satisfaction with follow up post-operative phone calls with standardized questions	2 days postop