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NCT Number: NCT06315582

Surgical Approach to Uterine Septum

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.

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Key information

Age range

22 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Medicine Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Milad Madgy, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Removal of uterine septum with hysteroscopic scissors without electrosurgery.

Procedure

Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue

Hysteroscopic septoplasty utilizing bipolar electrosurgery

Procedure

Hysteroscopic septoplasty utilizing bipolar electrosurgery

Primary outcomes

  1. Procedure-level variables: operative time hysteroscopic septoplasty

    Time frame: During the intervention/procedure/surgery

    We will measure time it takes to conduct procedure

  2. Procedure-level variables: Surgical Cost

    Time frame: During the surgery

    We will compare amount of money spent.

  3. Procedure-level variables: Fluid deficit

    Time frame: During the surgery

    We will measure amount of fluid deficit which is a number that is generate by hysteroscope.

  4. Resolution of uterine septum

    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

Secondary outcomes

  1. Compare adverse events

    Time frame: Immediate period-- 1 week post-operation

    Characterize and compare any potential adverse events related to the two surgical techniques for hysteroscopic septoplasty

  2. Comparing patient recovery and satisfaction

    Time frame: 2 days postop

    Comparing patient recovery and satisfaction with follow up post-operative phone calls with standardized questions

Study contacts

Contact information is provided by the study sponsor or research team.

Milad Madgy, MD

CONTACT

[email protected]

Sarah L Rodriguez, MD

CONTACT

[email protected]

7863011284

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Surgical Approach to Uterine Septum: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2024
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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