Intrauterine Stent Placement Following Hysteroscopic Septum Resection

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intraoperative placement of an inflated intrauterine pediatric foley catheter

    Procedure/Surgery

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

  • No Catheter placement

    Procedure/Surgery

    No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon

  • Hormonal Therapy Agent

    Drug

    2 weeks of oral estradiol (2 mg daily) or transdermal (two 0.1 mg patches changed twice weekly) estradiol supplementation followed by 1 week of oral or transdermal estradiol (same dosing as above) with oral medroxyprogesterone acetate (10 mg daily)

  • Oral antibiotics

    Drug

    100 mg of oral doxycycline twice daily or other appropriate antibiotic in allergic patients to be given while the intrauterine stent is in place

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheterExperimental treatment 3 interventions
Group B: Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheterActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

The rate of intrauterine adhesion formation following hysteroscopic septoplasty

Time frame
12 weeks

Secondary outcomes

1

Number of participants with Intraoperative complications

Time frame
12 weeks
2

Number of participants with postoperative complications

Time frame
12 weeks
3

Number of subjects completing postop intervention-hormone use

Time frame
12 weeks
4

Patient compliance - Post Operative - #subject with balloon remaining in place to post op visit

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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