Surgical Approach to Uterine Septum

March 11, 2024 updated by: Magdy Milad, MD, Northwestern University

Surgical Approach to Uterine Septum: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Medicine Prentice Women's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study Intervention A (control group)
Hysteroscopic septoplasty utilizing bipolar electrosurgery
Procedure: Hysteroscopic septoplasty utilizing bipolar electrosurgery
Hysteroscopic septoplasty utilizing bipolar electrosurgery
Experimental: Study Intervention B (study group)
Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue
Procedure: Removal of uterine septum with hysteroscopic scissors without electrosurgery.
Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure-level variables: operative time hysteroscopic septoplasty
Time Frame: During the intervention/procedure/surgery
We will measure time it takes to conduct procedure
During the intervention/procedure/surgery
Procedure-level variables: Surgical Cost
Time Frame: During the surgery
We will compare amount of money spent.
During the surgery
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.
During the surgery
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
Assess at 4 weeks post-op hysteroscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediate period-- 1 week post-operation
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
2 days postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

August 26, 2025

Study Completion (Estimated)

February 26, 2026

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00220487

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Treatment Side Effects

Clinical Trials on Hysteroscopic septoplasty utilizing bipolar electrosurgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe