Route B: Single site laparoscopy for Female Infertility
Phase-Based Progress Estimates
Effectiveness
Safety
The University of Texas Health Science Center at Houston, Houston, TX
Female Infertility+2 More
V-Notes surgery - DeviceEligibility
18 - 65
Female
What conditions do you have?
Select
Eligibility
18 - 65
Female
What conditions do you have?
Select
Study Summary
The purpose of this study is to compare and capture key elements of the patient experience, quality of recovery, preferences and satisfaction after laparoscopic salpingectomy done via 3 different routes.
Eligible Conditions
- Female Infertility
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 3 months post surgery
24 hours after surgery
Quality of recovery after surgery as assessed by the Quality of Recovery (QOR-40 )questionnaire
3 months post surgery
Cosmesis as assessed by the Body Image Questionnaire
Pain as assessed by the Dynamic Visual Analog Scale (VAS)
Pain as assessed by the Resting Visual Analog Scale (VAS)
Patient satisfaction as assessed by the satisfaction scale
Month 3
Change in sexual function as assessed by the Short version of the Female Sexual Function Index (FSFI)
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Route A: Traditional laparoscopy
1 of 3
Route B: Single site laparoscopy
1 of 3
Route C:V-Notes surgery"
1 of 3
Active Control
Experimental Treatment
150 Total Participants · 3 Treatment Groups
Primary Treatment: Route B: Single site laparoscopy · No Placebo Group · N/A
Route B: Single site laparoscopy
Device
Experimental Group · 1 Intervention: Single site laparoscopy · Intervention Types: DeviceRoute C:V-Notes surgery"
Device
Experimental Group · 1 Intervention: V-Notes surgery · Intervention Types: DeviceRoute A: Traditional laparoscopy
Device
ActiveComparator Group · 1 Intervention: Traditional laparoscopy · Intervention Types: DeviceTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months post surgery
Trial Background
Prof. Randa Jalloul, Associate Professor
Principal Investigator
The University of Texas Health Science Center, Houston
Closest Location: The University of Texas Health Science Center at Houston · Houston, TX
2008First Recorded Clinical Trial
1 TrialsResearching Female Infertility
190 CompletedClinical Trials
Eligibility Criteria
Age 18 - 65 · Female Participants · 3 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are scheduled to undergo an elective sterilization surgery regardless of parity.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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