Intrauterine Stent Placement Following Hysteroscopic Septum Resection

Weill Cornell Medicine (WCM)

Status: Not yet enrolling

Conditions: Intrauterine Adhesion

Treatments: Drug: Hormonal Therapy Agent; Procedure: Intraoperative placement of an inflated intrauterine pediatric foley catheter; Procedure: No Catheter placement; Drug: Oral antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT07032506

24-04027291

Details and patient eligibility

About

The study hopes to learn the best way to prevent internal scar tissue after septum removal. The use of an intrauterine foley catheter balloon may prevent the formation of adhesions following surgery.

Full description

This is an open label randomized controlled clinical trial of post-operative interventions to prevent intrauterine adhesion formation following hysteroscopic septoplasty. Individuals undergoing planned hysteroscopic resection of a known uterine septum with a length of ≥50% of the uterine cavity, as measured from the lower uterine segment to the inter-cornual line on 3D ultrasound or MRI will be randomized to either placement of an intrauterine foley catheter balloon for 7-10 days with hormonal supplementation or hormonal supplementation only. Individuals unwilling or unable to consent, those with a history of prior transmural uterine surgery, those with a history of a prior septum resection, history of prior surgery for intrauterine adhesions, or individuals in whom complete septum resection is unable to be performed in a single procedure will be excluded.

Patients will be screened by study investigators for eligibility. Patients will be identified if they are found to have a uterine septum during their evaluation for infertility or recurrent pregnancy loss or if previously identified by a referring provider. Investigators will obtain written informed consent in the patient's preferred language by person-to-person contact. Patients choosing to enroll will be randomized in a 1:1 allocation to one of two interventions:

Surgical technique in the form of electrocautery versus sharp resection will be at the surgeon's discretion. All patients will undergo a post-operative in-clinic 3D saline sonogram to assess adhesion formation within the first two menstrual cycles following the intervention, to be performed no later than 12 weeks following surgery.

Enrollment: 320 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 and above
• Patients electing to undergo hysteroscopic septoplasty following an informed consent and shared decision making process
• Uterine septum of at least 50% of the uterine cavity length as quantified on 3-dimensional saline infusion ultrasound

Exclusion criteria

• Unwilling or unable to provide informed consent
• History of prior uterine septum resection
• History of prior transmural uterine surgery
• Preexisting intrauterine adhesions or prior treatment for intrauterine adhesions
• Individuals in whom complete septum resection is unable to be performed as a single procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter

Experimental group

Description:

Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.

Treatment:

Drug: Oral antibiotics

Drug: Hormonal Therapy Agent

Procedure: Intraoperative placement of an inflated intrauterine pediatric foley catheter

Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter

Active Comparator group

Description:

No placement of an inflated intrauterine pediatric foley catheter

Treatment:

Procedure: No Catheter placement

Drug: Hormonal Therapy Agent