Health TrialsbyHealthPanel

Surgical Approach to Uterine Septum

ConditionsUterine SeptumSurgical ComplicationSeptum; UterusTreatment Side EffectsTreatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22-44
SponsorNorthwestern University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Have a confirmed septum (>1.0 cm) confirmed with 3D imaging and/or MRI

20-44 years old

Disqualifiers

Known tubal disease

Bleeding diastasis

No blood thinners

No concurrent laparoscopy scheduled

Trial design

Design model

Parallel

Treatments tested in this trial

  • Removal of uterine septum with hysteroscopic scissors without electrosurgery.

    Procedure/Surgery

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

  • Hysteroscopic septoplasty utilizing bipolar electrosurgery

    Procedure/Surgery

    Hysteroscopic septoplasty utilizing bipolar electrosurgery

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Study Intervention A (control group)Active comparator 1 intervention
Group B: Study Intervention B (study group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Procedure-level variables: operative time hysteroscopic septoplasty

We will measure time it takes to conduct procedure

Time frame
During the intervention/procedure/surgery
2

Procedure-level variables: Surgical Cost

We will compare amount of money spent.

Time frame
During the surgery
3

Procedure-level variables: Fluid deficit

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

Time frame
During the surgery
4

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

Time frame
Assess at 4 weeks post-op hysteroscopy

Secondary outcomes

1

Compare adverse events

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

Time frame
Immediate period-- 1 week post-operation
2

Comparing patient recovery and satisfaction

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

Time frame
2 days postop

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov
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