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Complete salpingectomy using a hand-held bipolar energy instrument for Pregnancy

N/A
Recruiting
Led By Jean W Thermolice, MD
Research Sponsored by Inova Health Care Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day of surgery up to 30 days pospartum
Awards & highlights

Study Summary

One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide. A preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes.

Eligible Conditions
  • Pregnancy
  • Tubal Ligation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hemoglobin levels on postoperative day one
Secondary outcome measures
Adjacent organ damage
Completion rate of sterilization
Cost
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Complete salpingectomy using traditional suture ligationExperimental Treatment1 Intervention
Group II: Complete salpingectomy using a hand-held bipolar energy instrumentExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Inova Health Care ServicesLead Sponsor
69 Previous Clinical Trials
21,355 Total Patients Enrolled
Jean W Thermolice, MDPrincipal InvestigatorInova Fairfax Medical Campus
1 Previous Clinical Trials
120 Total Patients Enrolled

Frequently Asked Questions

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~600 spots leftby Dec 2024